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Welcome to the AI Assistant app Wiki

a community-driven platform of AI-powered tools crafted by and for medtech professionals.

The AI Assistant apps are designed to enhance productivity and enable medtech RA and QA professionals to focus on strategic tasks.

Leverage data-driven insights for enhanced safety and post market surveillance.

Stay ahead with real-time access to the latest data on public databases collating adverse events, device deficiencies, and enforcement actions.

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 Privacy Notice and Disclaimer.

Getting started

AI Assistant app Overview

Installation

Licensing

Frequently Asked Questions

Privacy policy

License terms

AI Assistant apps

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.

Email info@medicalsysconsult.com for inquiries about creating a custom AI Assistant app version.

AI-Analysis-Assistant

** Last updated 05/29/2024
AI and data mining to analyze adverse events from MAUDE, facilitating efficient data analysis and informed decision-making

AI-Complaint-Assistant with prompt

** Last updated 04/12/2024
Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.

AI-Complaint-Assistant for document

** Last updated 04/12/2024
Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.

AI-Risk-Assistant

** Last updated 04/12/2024
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.

AI-Documentation-Assistant

** Last updated 04/12/2024
Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.

AI-Document-Assistant

** Last updated 04/21/2024
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.

AI-Automation-Assistant

** Last updated 04/30/2024
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.

AI-510(k)-Assistant

** Last updated 04/30/2024
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.

AI-Watchdog-Assistant

** Last updated 05/30/2024
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.

AI-QMSR-Gap-Assistant

** Coming Soon.
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.