Launching today
PreQMS
AI-powered FDA 510(k) documentation and traceability
4 followers
AI-powered FDA 510(k) documentation and traceability
4 followers
PreQMS helps medical device teams generate FDA 510(k) documentation, manage requirements, and maintain end-to-end traceability using AI.
How does it actually keep the AI-generated content aligned with our existing risk files when our team updates a requirement after the docs are already drafted?
Congrats on the launch. One thing that would really help our team is a built-in review workflow where reviewers can leave inline comments on specific sections of the 510(k) draft and track them to resolution, so we stop juggling feedback across email and Word.
The traceability matrix view is really well thought out, especially how it links requirements to risks without making you click through five menus. Nice to see a tool that actually understands the FDA workflow instead of just slapping AI on a generic docs editor.