Main Page: Difference between revisions

| [[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

| [[AI-Complaint-Prompt-Assistant]] || Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions. || 04/12/2024

| [[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

| [[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

| [[AI-Documentation-Assistant]] || Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards. || 04/12/2024

| [[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

| [[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

| [[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

| [[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

| [[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