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PreQMS
AI-powered FDA 510(k) documentation and traceability
7 followers
AI-powered FDA 510(k) documentation and traceability
7 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.
Curious how it handles the actual 510(k) submission assembly though, does it produce a complete ready-to-submit package or just the supporting docs you still have to compile yourself?
@niyazi1164394 PreQMS focuses on the design-control record and submission-readiness, not the final eSTAR assembly. So it produces and keeps submission-ready the supporting documentation — software requirements, V&V, risk, cybersecurity, and the traceability across them — and tells you where the gaps are before you compile. It doesn't yet output a complete, eSTAR-formatted 510(k) package (cover letter, 510(k) Summary, predicate comparison, etc.) — that final assembly is still yours (or your consultant's).
The way to think about it: PreQMS makes sure the contents are complete, coherent, and defensible so assembly is fast and you're not discovering gaps at the RTA stage — rather than auto-generating the submission itself. Full eSTAR package assembly is on the roadmap; today it's the readiness layer underneath it. Happy to show exactly what exports look like if useful.
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.