Launching today
PreQMS
AI-powered FDA 510(k) documentation and traceability
5 followers
AI-powered FDA 510(k) documentation and traceability
5 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?
@eydabacanagasw Great question. PreQMS doesn't treat AI-generated content as static text. Requirements, risks, hazards, mitigations, tests, and design artifacts are all linked through traceability. When a requirement changes, PreQMS identifies the downstream documentation that may be impacted, updates the traceability relationships, and flags affected artifacts for review. The AI then helps regenerate or revise only the impacted sections, while keeping the human in control of approval. The goal is to prevent documentation drift instead of discovering inconsistencies just before a submission.
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.
@doyranl58403 Thanks! And this is right in the wheelhouse — PreQMS already does exactly this. Reviewers leave inline comments on specific requirements/sections, everything's threaded to resolution with status, and it's tied into a review workflow with sign-off — so feedback lives on the record itself instead of scattered across email and Word versions. The whole point was to kill the "which Word doc has the latest comments" problem.
Would love to show you how it maps to your team's flow — happy to do a quick walkthrough on your actual review process, or drop you a link. Either way, appreciate you calling this out.
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.
@muhammetbagqve Thank you! That was exactly the goal. We wanted traceability to feel like a natural part of development instead of a compliance exercise. Rather than forcing teams to stitch together spreadsheets and documents, PreQMS keeps requirements, risks, tests, and design artifacts connected from day one.