http://medicalsysconsult.com/aiassistant/api.php?action=feedcontributions&feedformat=atom&user=Waghanna 2026-06-29T07:23:03Z User contributions MediaWiki 1.41.1 http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=352 2024-06-14T01:11:42Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant|MAUDE Analysis]] || [[AI-Analysis-Assistant|Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends.]] || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Prompt-Assistant|Complaint Prompt]] || [[AI-Complaint-Prompt-Assistant|Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.]] || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Document-Assistant|Complaint Document]] || [[AI-Complaint-Document-Assistant|Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.]] || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant|Risk Assessment]] || [[AI-Risk-Assistant|Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.]] || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant|MDF Documentation]] || [[AI-Documentation-Assistant|Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.]] || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant|Document Chat]] || [[AI-Document-Assistant|Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.]] || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant|Automation]] || [[AI-Automation-Assistant|Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.]] || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant|510(k)]] || [[AI-510(k)-Assistant|Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.]] || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant|Watchdog]] || [[AI-Watchdog-Assistant|Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email.]] || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant|QMSR Gap Analysis]] || [[AI-QMSR-Gap-Assistant|Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements, ensuring you're well prepared for the February 2nd, 2026 deadline.]] || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=351 2024-06-14T01:02:33Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> }<br /> <br /> td a:link { <br /> text-decoration: none; <br /> } <br /> td a:visited { <br /> text-decoration: none; <br /> } <br /> td a:hover { <br /> text-decoration: none; <br /> } <br /> td a:active { <br /> text-decoration: none; <br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=350 2024-06-14T01:01:57Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> height:100% !important;<br /> }<br /> <br /> td a:link { <br /> text-decoration: none; <br /> } <br /> td a:visited { <br /> text-decoration: none; <br /> } <br /> td a:hover { <br /> text-decoration: none; <br /> } <br /> td a:active { <br /> text-decoration: none; <br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=349 2024-06-14T01:00:37Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> height:100%!important;<br /> }<br /> <br /> td a:link { <br /> text-decoration: none; <br /> } <br /> td a:visited { <br /> text-decoration: none; <br /> } <br /> td a:hover { <br /> text-decoration: none; <br /> } <br /> td a:active { <br /> text-decoration: none; <br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=348 2024-06-14T00:55:10Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> height:100%;<br /> }<br /> <br /> td a:link { <br /> text-decoration: none; <br /> } <br /> td a:visited { <br /> text-decoration: none; <br /> } <br /> td a:hover { <br /> text-decoration: none; <br /> } <br /> td a:active { <br /> text-decoration: none; <br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=347 2024-06-14T00:53:47Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant]] || Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends. || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Prompt-Assistant]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Document-Assistant]] || Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews. || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant]] || Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management. || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant|AI-Document-Assistant]] || [[AI-Document-Assistant|Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.]] || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant]] || Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments. || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant]] || Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant]] || Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant]] || Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=346 2024-06-14T00:52:50Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> }<br /> <br /> td a:link { <br /> text-decoration: none; <br /> } <br /> td a:visited { <br /> text-decoration: none; <br /> } <br /> td a:hover { <br /> text-decoration: none; <br /> } <br /> td a:active { <br /> text-decoration: none; <br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=345 2024-06-14T00:51:28Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> <br /> link { <br /> text-decoration: none; <br /> } <br /> visited { <br /> text-decoration: none; <br /> } <br /> hover { <br /> text-decoration: none; <br /> } <br /> active { <br /> text-decoration: none; <br /> }<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=344 2024-06-14T00:49:58Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> <br /> td a {<br /> display:block;<br /> width:100%;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=343 2024-06-14T00:49:35Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=342 2024-06-14T00:49:00Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant]] || Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends. || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Prompt-Assistant]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Document-Assistant]] || Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews. || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant]] || Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management. || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant]] || [[AI-Document-Assistant|Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.]] || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant]] || Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments. || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant]] || Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant]] || Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant]] || Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=341 2024-06-14T00:48:45Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }<br /> td a {<br /> display:block;<br /> width:100%;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=340 2024-06-14T00:42:18Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:#89CFF0;<br /> cursor: pointer;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=339 2024-06-14T00:41:44Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:babyblue;<br /> cursor: pointer;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=338 2024-06-14T00:41:31Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:baby blue;<br /> cursor: pointer;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=337 2024-06-14T00:39:18Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}<br /> tr:hover{<br /> background:lightblue;<br /> }</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Prompt-Assistant&diff=336 2024-06-14T00:36:03Z

<p>Waghanna: </p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Prompt.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant with prompt]]'''<br /> <br /> ==App Description==<br /> <br /> [[File:Complaints-assistant-illustration.mp4|800px]]<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px|center]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. This version can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders. See [[AI-Complaint-Document-Assistant]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Document-Assistant&diff=335 2024-06-14T00:35:27Z

<p>Waghanna: </p> <hr /> <div>==App Files==<br /> <br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Document.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt &lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> <br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant for document]]'''<br /> <br /> ==App Description==<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint assessments using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency. This AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. Additionally, it can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders, to allow for a retrospective assessment of old complaint records.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions from specified file source, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from a user interface prompt allowing for complaint assessments in real-time or research use. See [[AI-Complaint-Prompt-Assistant]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=334 2024-06-14T00:34:49Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant]] || Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends. || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Prompt-Assistant]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Document-Assistant]] || Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews. || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant]] || Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management. || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant]] || Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document. || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant]] || Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments. || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant]] || Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant]] || Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant]] || Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Document-Assistant&diff=333 2024-06-14T00:30:59Z

<p>Waghanna: Waghanna moved page AI-Complaint-Assistant for document to AI-Complaint-Document-Assistant without leaving a redirect</p> <hr /> <div>==App Files==<br /> <br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Document.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt &lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> <br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant for document]]'''<br /> <br /> ==App Description==<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint assessments using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency. This AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. Additionally, it can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders, to allow for a retrospective assessment of old complaint records.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions from specified file source, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from a user interface prompt allowing for complaint assessments in real-time or research use. See [[AI-Complaint-Assistant with prompt]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=332 2024-06-14T00:30:33Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {{row hover highlight}}<br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant]] || Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends. || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Prompt-Assistant]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Document-Assistant]] || Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews. || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant]] || Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management. || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant]] || Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document. || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant]] || Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments. || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant]] || Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant]] || Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant]] || Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Prompt-Assistant&diff=331 2024-06-14T00:29:54Z

<p>Waghanna: Waghanna moved page AI-Complaint-Assistant with prompt to AI-Complaint-Prompt-Assistant without leaving a redirect</p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Prompt.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant with prompt]]'''<br /> <br /> ==App Description==<br /> <br /> [[File:Complaints-assistant-illustration.mp4|800px]]<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px|center]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. This version can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders. See [[AI-Complaint-Assistant for document]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=330 2024-06-14T00:27:34Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> <br /> {{row hover highlight}}<br /> {| class=&quot;mw-datatable wikitable&quot; style=&quot;margin:auto&quot;<br /> |+ AI Assistant apps<br /> |-<br /> ! App Page !! App Description !! Last Updated<br /> |-<br /> | [[AI-Analysis-Assistant]] || Enhances risk management decision-making by using AI to analyze 1000s of adverse event data from the MAUDE database based on given criteria, processes it in chunks for semantic analysis, and generates comprehensive reports with top device problems, manufacturer and device information, and related safety trends. || 05/29/2024<br /> |-<br /> | [[AI-Complaint-Assistant with prompt]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024<br /> |-<br /> | [[AI-Complaint-Assistant for document]] || Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews. || 04/12/2024<br /> |-<br /> | [[AI-Risk-Assistant]] || Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management. || 04/12/2024<br /> |-<br /> | [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024<br /> |-<br /> | [[AI-Document-Assistant]] || Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document. || 04/21/2024<br /> |-<br /> | [[AI-Automation-Assistant]] || Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments. || 04/30/2024<br /> |-<br /> | [[AI-510(k)-Assistant]] || Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process. || 04/30/2024<br /> |-<br /> | [[AI-Watchdog-Assistant]] || Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email. || 05/30/2024<br /> |-<br /> | [[AI-QMSR-Gap-Assistant]] || Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline. || Coming Soon<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app for your specific needs. &lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=329 2024-06-13T22:47:14Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=328 2024-06-13T22:46:54Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the AI Assistant app Wiki&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and post market surveillance.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant apps are not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app version. &lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ::; &lt;h4&gt;[[AI-Analysis-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/29/2024&lt;/i&gt;&lt;br/&gt;AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant with prompt]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant for document]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.<br /> ::; &lt;h4&gt;[[AI-Risk-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.<br /> ::; &lt;h4&gt;[[AI-Documentation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.<br /> ::; &lt;h4&gt;[[AI-Document-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/21/2024&lt;/i&gt;&lt;br/&gt;Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.<br /> ::; &lt;h4&gt;[[AI-Automation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.<br /> ::; &lt;h4&gt;[[AI-510(k)-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.<br /> ::; &lt;h4&gt;[[AI-Watchdog-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/30/2024&lt;/i&gt;&lt;br/&gt;Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email.<br /> ::; &lt;h4&gt;[[AI-QMSR-Gap-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Coming Soon.&lt;/i&gt;&lt;br/&gt;Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=327 2024-06-13T22:36:20Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 24px}</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=326 2024-06-13T22:35:30Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 30px}</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=325 2024-06-13T22:33:45Z

<p>Waghanna: </p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 20px}</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=MediaWiki:Common.css&diff=324 2024-06-13T22:33:06Z

<p>Waghanna: Created page with &quot;/* CSS placed here will be applied to all skins */ * {font-size: 16px}&quot;</p> <hr /> <div>/* CSS placed here will be applied to all skins */<br /> * {font-size: 16px}</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Licensing&diff=323 2024-06-13T22:22:36Z

<p>Waghanna: </p> <hr /> <div><br /> ==License Activation==<br /> [[Media: AI-Assistant-License.zip|License app]]<br /> <br /> To run the AI Assistant apps on a Windows machine, you will need to obtain a license. Follow these steps to obtain your license:<br /> <br /> #Download the [[Media: AI-Assistant-License.zip|License app]] zip file, extract it, and run the ''AIA_LICENSE_SERIAL.exe'' executable.<br /> #Take a screenshot of the License app window (displaying your machine's Serial Number and Node ID).<br /> #Email the screenshot along with your first name, last name, organization, and phone number to [mailto:info@medicalsysconsult.com info@medicalsysconsult.com].<br /> #You'll receive installation instructions afterward.<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Please refer to the license terms in the [[License|End-User License Agreement (EULA)]].&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ==Pricing==<br /> <br /> {| style=&quot;width: 100%; line-height:25px; margin: 0 auto;&quot;<br /> | &lt;h1&gt;Monthly Subscription &lt;br/&gt;Only $250 per user/month&lt;/h1&gt;&lt;br/&gt;<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left;&quot; | ☆ Unlimited access to all AI Assistant apps - including new and updated apps perpetually released.<br /> |-<br /> ! style=&quot;font-style:italic; text-align:left;&quot; | ☆ Unlimited reports - up to 10,000 pages.<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left;&quot; | ☆ Custom AI Assistant apps - with up to 2 hours per month for consulting and training, e.g., specific queries, specific data report, custom templates. <br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for group discounts applicable to 5 or more users within the same organization.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for custom app development.&lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Licensing&diff=322 2024-06-13T20:40:58Z

<p>Waghanna: /* Pricing */</p> <hr /> <div><br /> ==License Activation==<br /> [[Media: AI-Assistant-License.zip|License app]]<br /> <br /> To run the AI Assistant apps on a Windows machine, you will need to obtain a license. Follow these steps to obtain your license:<br /> <br /> #Download the [[Media: AI-Assistant-License.zip|License app]] zip file, extract it, and run the ''AIA_LICENSE_SERIAL.exe'' executable.<br /> #Take a screenshot of the License app window (displaying your machine's Serial Number and Node ID).<br /> #Email the screenshot along with your first name, last name, organization, and phone number to [mailto:info@medicalsysconsult.com info@medicalsysconsult.com].<br /> #You'll receive installation instructions afterward.<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Please refer to the license terms in the [[License|End-User License Agreement (EULA)]].&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ==Pricing==<br /> <br /> {| style=&quot;width: 100%; line-height:25px; margin: 0 auto;&quot;<br /> | &lt;h1&gt;Monthly Subscription &lt;br/&gt;Only $250 per user/month&lt;/h1&gt;&lt;br/&gt;<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left;&quot; | ☆ Access all AI Assistant apps - including new apps perpetually released.<br /> |-<br /> ! style=&quot;font-style:italic; text-align:left;&quot; | ☆ Unlimited reports - up to 10,000 pages.<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left;&quot; | ☆ Custom AI Assistant apps - for specific queries, report templates, etc., up to 2 hours per month included for consulting and training. <br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for group discounts applicable to 5 or more users within the same organization.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for custom app development.&lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Licensing&diff=321 2024-06-13T20:04:55Z

<p>Waghanna: </p> <hr /> <div><br /> ==License Activation==<br /> [[Media: AI-Assistant-License.zip|License app]]<br /> <br /> To run the AI Assistant apps on a Windows machine, you will need to obtain a license. Follow these steps to obtain your license:<br /> <br /> #Download the [[Media: AI-Assistant-License.zip|License app]] zip file, extract it, and run the ''AIA_LICENSE_SERIAL.exe'' executable.<br /> #Take a screenshot of the License app window (displaying your machine's Serial Number and Node ID).<br /> #Email the screenshot along with your first name, last name, organization, and phone number to [mailto:info@medicalsysconsult.com info@medicalsysconsult.com].<br /> #You'll receive installation instructions afterward.<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Please refer to the license terms in the [[License|End-User License Agreement (EULA)]].&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ==Pricing==<br /> <br /> &lt;br/&gt;<br /> <br /> {| style=&quot;width: 500px; line-height:25px; margin: 0 auto;&quot;<br /> | &lt;h1&gt;Monthly Subscription &lt;br/&gt;Only $250 per user/month&lt;/h1&gt;&lt;br/&gt;<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left; width:250px;&quot; | Access all AI Assistant apps - including new apps perpetually released<br /> |-<br /> ! style=&quot;font-style:italic; text-align:left; width:250px;&quot; | Unlimited reports<br /> |-<br /> ! style=&quot;font-style:italic; text-align:left; width:250px;&quot; | Automation and email notifications<br /> |-<br /> ! style=&quot;font-style: italic; text-align:left; width:250px;&quot; | Custom AI Assistant apps - specific research queries, templates, etc.<br /> |}<br /> <br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for group discounts applicable to 5 or more users within the same organization.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for custom app development.&lt;/div&gt;&lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-QMSR-Gap-Assistant&diff=320 2024-06-03T19:28:35Z

<p>Waghanna: Created page with &quot;&lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt; &#039;&#039;&#039;Coming Soon.&#039;&#039;&#039; Our team is rigorously testing the AI-QMSR Gap Assistant to optimize its accuracy and processing speed. Expect its launch in a couple of weeks!&lt;/div&gt; &lt;/blockquote&gt;&quot;</p> <hr /> <div>&lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Coming Soon.''' Our team is rigorously testing the AI-QMSR Gap Assistant to optimize its accuracy and processing speed. Expect its launch in a couple of weeks!&lt;/div&gt;<br /> &lt;/blockquote&gt;</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=319 2024-06-03T19:24:41Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the '''AI Assistant app Wiki'''&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant app enhances productivity and enables medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and performance in your medical device operations.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest published data.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant app is not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app version. &lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ::; &lt;h4&gt;[[AI-Analysis-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/29/2024&lt;/i&gt;&lt;br/&gt;AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant with prompt]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant for document]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.<br /> ::; &lt;h4&gt;[[AI-Risk-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.<br /> ::; &lt;h4&gt;[[AI-Documentation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.<br /> ::; &lt;h4&gt;[[AI-Document-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/21/2024&lt;/i&gt;&lt;br/&gt;Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.<br /> ::; &lt;h4&gt;[[AI-Automation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.<br /> ::; &lt;h4&gt;[[AI-510(k)-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.<br /> ::; &lt;h4&gt;[[AI-Watchdog-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/30/2024&lt;/i&gt;&lt;br/&gt;Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email.<br /> ::; &lt;h4&gt;[[AI-QMSR-Gap-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Coming Soon.&lt;/i&gt;&lt;br/&gt;Stay ahead of the curve! The AI-QMSR Gap Assistant is currently under testing, and it is specifically designed to simplify your QMSR transition path. This AI-powered tool will scour your QMS documents and identify potential gaps against ISO 13485:2016 requirements and QMSR Subpart B – Supplemental Provisions, ensuring you're well prepared for the February 2nd, 2026 deadline.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=318 2024-06-03T01:56:37Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the '''AI Assistant app Wiki'''&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant app enhances productivity and enables medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and performance in your medical device operations.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest published data.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant app is not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app version. &lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ::; &lt;h4&gt;[[AI-Analysis-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/29/2024&lt;/i&gt;&lt;br/&gt;AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant with prompt]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant for document]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.<br /> ::; &lt;h4&gt;[[AI-Risk-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.<br /> ::; &lt;h4&gt;[[AI-Documentation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/12/2024&lt;/i&gt;&lt;br/&gt;Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.<br /> ::; &lt;h4&gt;[[AI-Document-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/21/2024&lt;/i&gt;&lt;br/&gt;Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.<br /> ::; &lt;h4&gt;[[AI-Automation-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.<br /> ::; &lt;h4&gt;[[AI-510(k)-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 04/30/2024&lt;/i&gt;&lt;br/&gt;Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.<br /> ::; &lt;h4&gt;[[AI-Watchdog-Assistant]]&lt;/h4&gt;:&lt;i&gt;** Last updated 05/30/2024&lt;/i&gt;&lt;br/&gt;Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=File:Basic-Watchdog-Sample.zip&diff=317 2024-05-30T19:02:51Z

<p>Waghanna: </p> <hr /> <div></div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Sample_Files:_AI-Watchdog-Assistant&diff=316 2024-05-30T19:02:18Z

<p>Waghanna: Created page with &quot;&lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;&#039;&#039;&#039;Note:&#039;&#039;&#039; Community members can edit this page.&lt;/div&gt;&lt;/blockquote&gt; You can share your own app files on this page. Please include a brief description of your app files. ==Sample App Files== Media: Basic-Watchdog-Sample.zip Description: Settings include Watchdog settings to mine for FDA Warning Letters issued from 04/30/2024.&quot;</p> <hr /> <div>&lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' Community members can edit this page.&lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> You can share your own app files on this page. Please include a brief description of your app files.<br /> <br /> ==Sample App Files==<br /> [[Media: Basic-Watchdog-Sample.zip]]<br /> Description: Settings include Watchdog settings to mine for FDA Warning Letters issued from 04/30/2024.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=File:AI-Watchdog-Assistant.zip&diff=315 2024-05-30T19:00:23Z

<p>Waghanna: </p> <hr /> <div></div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Watchdog-Assistant&diff=314 2024-05-30T18:59:06Z

<p>Waghanna: Created page with &quot;==App Files== &lt;blockquote&gt; Application executable: Media: AI-Watchdog-Assistant.zip &lt;/blockquote&gt; {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot; | &lt;strong&gt;Settings.txt&lt;/strong&gt; |- | CONFIG:Vertex-V1.0 // identifies schema version (readonly) web-url-table: // URL of website to data mine with links in a table web-url-page: // URL of website to data mine with links on a page limit: // Maximum number...&quot;</p> <hr /> <div>==App Files==<br /> <br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Watchdog-Assistant.zip]]<br /> &lt;/blockquote&gt;<br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> web-url-table: // URL of website to data mine with links in a table<br /> <br /> web-url-page: // URL of website to data mine with links on a page<br /> <br /> limit: // Maximum number of warning letters to include<br /> <br /> filter-section: // (Optional) Section of website to filter on<br /> <br /> filter-include: // (Optional) Keyword to include in filter<br /> <br /> filter-exclude: // (Optional) Keyword to exclude in filter<br /> <br /> filter-from-date: // Minimum date to filter on<br /> <br /> report-title: // Output document title<br /> <br /> log-file-location: // File path for log file used to track warning letters that are processed<br /> <br /> AI-SummaryPrompt: // Prompt for AI to process document fetched from website<br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> <br /> See the sample files page for example templates.<br /> <br /> '''[[Sample Files: AI-Watchdog-Assistant]]'''<br /> <br /> ==App Description==<br /> <br /> '''App Use Case:''' Watchdog Assistant is designed to streamline your information gathering process. It eliminates the need to manually check websites for updates by continuously monitoring your chosen online destinations. This AI-powered assistant scours the web, mining data for new information that aligns with your specific criteria (keywords, dates, categories). Whether you're keeping tabs on industry trends, tracking regulatory changes, or monitoring competitor activity, Watchdog Assistant ensures you stay informed and ahead of the curve.<br /> <br /> '''App Functionality:''' Watchdog Assistant utilizes intelligent algorithms to extract relevant data from websites you specify. These algorithms analyze content based on your predefined criteria, filtering out irrelevant information and focusing only on what matters to you. Once it identifies a new piece of information that matches your set parameters, Watchdog Assistant goes a step further. It automatically generates concise summaries, condensing the information into easily digestible chunks. This allows you to quickly grasp the key points without having to wade through lengthy documents.<br /> <br /> '''Key Features:'''<br /> <br /> Automated Data Mining: Watchdog Assistant tirelessly hunts for new information across the web, eliminating the need for manual monitoring.<br /> Customizable Criteria: Define your search by specifying keywords, dates, and categories to ensure you receive only the updates relevant to your needs.<br /> Intelligent Summarization: Get clear and concise summaries of new information, allowing you to quickly understand the content and take action.<br /> 24/7 Monitoring &amp; Notification: Watchdog Assistant works tirelessly around the clock, notifying you instantly via email whenever new, relevant information is discovered.<br /> Email Delivery with Summaries Attached: Receive summaries directly in your inbox with the original information attached for further reference.<br /> <br /> By automating information gathering and delivering actionable insights, Watchdog Assistant empowers you to stay informed and make data-driven decisions faster.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=313 2024-05-30T18:49:32Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the '''AI Assistant app Wiki'''&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant app enhances productivity and enables medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and performance in your medical device operations.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest published data.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant app is not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app version. &lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ::; &lt;h4&gt;[[AI-Analysis-Assistant]] ** Last updated 05/29/2024&lt;/h4&gt;:AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant with prompt]]&lt;/h4&gt;:Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant for document]]&lt;/h4&gt;:Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.<br /> ::; &lt;h4&gt;[[AI-Risk-Assistant]]&lt;/h4&gt;:Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.<br /> ::; &lt;h4&gt;[[AI-Documentation-Assistant]]&lt;/h4&gt;:Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.<br /> ::; &lt;h4&gt;[[AI-Document-Assistant]]&lt;/h4&gt;:Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.<br /> ::; &lt;h4&gt;[[AI-Automation-Assistant]]&lt;/h4&gt;:Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.<br /> ::; &lt;h4&gt;[[AI-510(k)-Assistant]]&lt;/h4&gt;: Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.<br /> ::; &lt;h4&gt;[[AI-Watchdog-Assistant]]&lt;/h4&gt;:Watchdog Assistant scours websites you specify, mining for new information that matches your set criteria (keywords, dates, categories). It then creates clear, concise summaries and delivers them straight to your inbox via email.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=Main_Page&diff=312 2024-05-29T23:08:34Z

<p>Waghanna: </p> <hr /> <div>&lt;div style=&quot;background: #FAFAFA; padding: 20px; border: 1px solid gray; text-align: center;&quot;&gt;[[File:icon1-1.png|center|64px]]<br /> &lt;div style=&quot;font-size:2em;&quot;&gt;Welcome to the '''AI Assistant app Wiki'''&lt;/div&gt;&lt;p style=&quot;font-size:1.5em;&quot;&gt;a community-driven platform of AI-powered tools crafted by and for medtech professionals.&lt;/p&gt;&lt;/div&gt;<br /> <br /> <br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;The AI Assistant app enhances productivity and enables medtech RA and QA professionals to focus on strategic tasks.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Leverage data-driven insights for enhanced safety and performance in your medical device operations.&lt;/p&gt;<br /> &lt;p style=&quot;text-align:center; font-size:1.5em; &quot;&gt;Stay ahead with real-time access to the latest published data.&lt;/p&gt;<br /> <br /> &lt;blockquote&gt;&lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;<br /> '''Disclaimer:''' Please be aware that the AI Assistant app is not intended for making sole decisions on medical device safety or risk management. There's no expectation of privacy, and any data used may be publicly disclosed. Unauthorized use may result in disciplinary action or legal consequences. For details, refer to our [[AI Assistant wiki:Privacy policy|Privacy Notice]] and [[AI Assistant wiki:General disclaimer|Disclaimer]].&lt;/div&gt;<br /> &lt;/blockquote&gt;<br /> <br /> == Getting started ==<br /> &lt;!-- &lt;div style=&quot;padding-right:50px;&quot;&gt;[[Image:screenshot.png|right|300px|link=]]&lt;/div&gt; --&gt;<br /> :&lt;h4&gt;[[AI Assistant app Overview]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Installation]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Licensing]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[Frequently Asked Questions]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[AI_Assistant_wiki:Privacy_policy|Privacy policy]]&lt;/h4&gt;<br /> :&lt;h4&gt;[[License|License terms]]&lt;/h4&gt;<br /> <br /> <br /> == AI Assistant apps ==<br /> &lt;blockquote&gt; &lt;div style=&quot;background:LightYellow; padding: 20px; border: 1px solid gray;&quot;&gt;'''Note:''' New versions of the AI Assistant app will be published here as they become available. Apps updated in last 30 days will be marked with last update date.&lt;/div&gt;&lt;/blockquote&gt;<br /> &lt;blockquote&gt; &lt;div style=&quot;background: Lavender; padding: 20px; border: 1px solid gray;&quot;&gt;Email [mailto:info@medicalsysconsult.com info@medicalsysconsult.com] for inquiries about creating a custom AI Assistant app version. &lt;/div&gt;&lt;/blockquote&gt;<br /> <br /> ::; &lt;h4&gt;[[AI-Analysis-Assistant]] ** Last updated 05/29/2024&lt;/h4&gt;:AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant with prompt]]&lt;/h4&gt;:Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.<br /> ::; &lt;h4&gt;[[AI-Complaint-Assistant for document]]&lt;/h4&gt;:Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.<br /> ::; &lt;h4&gt;[[AI-Risk-Assistant]]&lt;/h4&gt;:Analyzes diverse data for proactive risk mitigation, leveraging AI and public data like Recalls Enforcement and FDA's MAUDE database, aiding data-driven decision-making in risk management.<br /> ::; &lt;h4&gt;[[AI-Documentation-Assistant]]&lt;/h4&gt;:Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.<br /> ::; &lt;h4&gt;[[AI-Document-Assistant]]&lt;/h4&gt;:Reads PDFs, organizes information, and answers user questions for research and literature review. Users can customize settings and enter any questions, with results show on screen and saved in a Word document.<br /> ::; &lt;h4&gt;[[AI-Automation-Assistant]]&lt;/h4&gt;:Runs scheduled tasks, to batch process one or more AI Assistant app, and sends an email to configured recipients with attachments of results. Easily customize task scheduling, email recipients, and attachments.<br /> ::; &lt;h4&gt;[[AI-510(k)-Assistant]]&lt;/h4&gt;: Automates 510(k) submission content preparation for eSTAR compliance. Extracts data from predicate device summaries, identifies similarities, and guides users in filling submission forms. Streamlines regulatory compliance and accelerates the submission process.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=File:Basic-Analysis.zip&diff=311 2024-05-29T23:05:43Z

<p>Waghanna: Waghanna uploaded a new version of File:Basic-Analysis.zip</p> <hr /> <div></div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Analysis-Assistant&diff=310 2024-05-29T23:04:29Z

<p>Waghanna: </p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Analysis-Assistant.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // MAUDE example field<br /> <br /> device.device_report_product_code: // MAUDE example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-AnalysisPrompt: // Prompt that analyzes the MDR data to identify trends and patterns in adverse event occurrence<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the information collected from the MDR records <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 10000, range: 100-30000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 1.0, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 2, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-8192)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Analysis-Assistant]]'''<br /> <br /> ==App Description==<br /> <br /> '''App Use Case:'''<br /> The AI-Analysis-Assistant app is a powerful tool designed to enhance decision-making and productivity by leveraging artificial intelligence and data mining of vast amounts of data, specifically focused on adverse events (MAUDE: Manufacturer and User Facility Device Experience). It supports a wide range of data analysis tasks using natural language and includes highly extensible options for analyzing unstructured data. From summarizing data analytics and trends to uncovering hidden patterns and insights, to simulating what-if scenarios with objective data-driven results, the Analysis-Assistant app enables users to consider multiple factors, analyze vast amounts of data efficiently, and make well-informed, bias-free decisions.<br /> <br /> '''App Functionality:'''<br /> The AI-Analysis-Assistant app reads a Settings file that contains criteria for adverse events and pulls the up to date matching records from MAUDE. The unstructured data is then chunked to optimize semantic vector processing adopting a retrieval augmented generation approach. The model then performs the data analysis prompts given in the Settings file on the data chunked data and injects the results in a predefined report template. <br /> <br /> Diagram outlining the processing steps of the Analysis Assistant:<br /> <br /> [[Image: AI-Analysis-Process.jpg|600px]]<br /> <br /> A PDF document is generated containing the analysis results.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=File:AI-Analysis-Assistant.zip&diff=309 2024-05-29T23:01:20Z

<p>Waghanna: Waghanna uploaded a new version of File:AI-Analysis-Assistant.zip</p> <hr /> <div>== Summary ==<br /> AI Analysis Assistant app</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Prompt-Assistant&diff=308 2024-05-19T16:30:19Z

<p>Waghanna: /* App Description */</p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Prompt.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant with prompt]]'''<br /> <br /> ==App Description==<br /> <br /> [[File:Complaints-assistant-illustration.mp4|800px]]<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px|center]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. This version can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders. See [[AI-Complaint-Assistant for document]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Prompt-Assistant&diff=307 2024-05-16T22:35:29Z

<p>Waghanna: </p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Prompt.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant with prompt]]'''<br /> <br /> ==App Description==<br /> <br /> [[File:Complaints-assistant-illustration.mp4|center|800px]]<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px|center]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. This version can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders. See [[AI-Complaint-Assistant for document]] for more info.</div>

Waghanna http://medicalsysconsult.com/aiassistant/index.php?title=AI-Complaint-Prompt-Assistant&diff=306 2024-05-16T22:25:21Z

<p>Waghanna: </p> <hr /> <div>==App Files==<br /> &lt;blockquote&gt;<br /> Application executable: [[Media: AI-Complaint-Assistant-Prompt.zip]]<br /> <br /> Reference file: [[Media: openFDA device_search_fields.xlsx]]<br /> <br /> {| role=&quot;presentation&quot; style=&quot;min-width:250px;&quot; class=&quot;wikitable mw-collapsible mw-collapsed code-sample&quot;<br /> | &lt;strong&gt;Settings.txt&lt;/strong&gt;<br /> |-<br /> | <br /> CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)<br /> <br /> https_url1: // openFDA api for source data<br /> <br /> limit1: // limit of query results<br /> <br /> report_title: // title of output report<br /> <br /> data1_fields: // data fields to be analyzed in MDR query results<br /> <br /> KEYWORD1-SEARCH: // general keyword search terms (matched in any field)<br /> <br /> SEARCH1-FIELDS:SEARCH1-TERMS // query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields<br /> <br /> date_received: // example field<br /> <br /> device.device_report_product_code: // example field<br /> <br /> SORT1-FIELD:SORT1-TERM // query results sorting<br /> date_received:desc<br /> <br /> COUNT1-FIELD:COUNT1-TERM // query count field/term<br /> <br /> AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem<br /> <br /> AI-CountSummaryPrompt: // Prompt that counts the instances of items<br /> <br /> AI-ProblemSimilarityPrompt: // Prompt that summarizes the problem similarity to a product problem<br /> <br /> AI-MDRSimilarityPrompt: // Prompt that analyzes the similarity between input problem and MAUDE results matching query criteria<br /> <br /> AI-ReportSummaryPrompt: // Prompt that summarizes the most similar problems <br /> <br /> AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)<br /> <br /> AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)<br /> <br /> AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)<br /> <br /> AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)<br /> <br /> AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)<br /> |}<br /> &lt;/blockquote&gt;<br /> ----<br /> See the sample files page for example settings and reports.<br /> <br /> '''[[Sample Files: AI-Complaint-Assistant with prompt]]'''<br /> <br /> ==App Description==<br /> <br /> [[File:Complaints-assistant-illustration.mp4|800px|center]]<br /> <br /> '''App Use Case:'''<br /> The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency.<br /> <br /> '''App Functionality:'''<br /> The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file.<br /> <br /> In cases where there are no similar records found for the complaint input, expanding the MAUDE search to include additional device codes under the same regulation number is possible with a small change in the Settings file. This approach opens up possibilities for broader analysis and leads to more comprehensive insights.<br /> <br /> Using the MAUDE query results, the AI Assistant matches the top problems similar to the provided complaint, reporting the estimated similarity for each along with relevant reference information.<br /> <br /> Diagram outlining the processing steps of the Complaints Assistant:<br /> <br /> [[Image: AI-Complaint-Handling-Process.jpg|800px|center]]<br /> <br /> A PDF document is generated containing results detailing the top product problems associated with the specified product code, along with additional analytics for each product problem. It also includes the highest matching Medical Device Reports (MDRs) with estimated similarity scores and detailed explanations for their similarity.<br /> <br /> '''Additional information:'''<br /> Another version of this AI Assistant accepts complaint descriptions from locally provided PDF or Word documents, as well as from network locations. This version can operate in batch mode, processing one or more documents within a specified folder path defined in the Settings file, automatically including documents from sub-folders. See [[AI-Complaint-Assistant for document]] for more info.</div>

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