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

Welcome to the AI Assistant app Wiki

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

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.

AI Assistant apps

App Page	App Description	Last Updated
MAUDE Analysis	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
Complaint Prompt	Streamlines complaint intake in call centers by automating reportability prediction, optimizing resource allocation, and expediting MDR submissions.	04/12/2024
Complaint Document	Automates complaint assessments, expediting MDR submissions, and accepting complaints from various sources, including batch mode for retrospective reviews.	04/12/2024
Risk Assessment	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
MDF Documentation	Streamlines medical device documentation, ensuring compliance with applicable regulations and state-of-the-art standards.	04/12/2024
Document Chat	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
Automation	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
510(k)	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
Watchdog	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
QMSR Gap Analysis	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

Email info@medicalsysconsult.com for inquiries about creating a custom AI Assistant app for your specific needs.