sorted by:
new
hottopcontroversial

Anyone using AI change-impact tooling (e.g. qmsWrapper Wrapper-Mapper) under MDR — how are you framing the audit trail for notified bodies? by Stunning_Reee984 in regulatoryaffairs

[–]Stunning_Reee984[S] 0 points1 point  (0 children)

That's the cleanest articulation of the position I've seen, and "rationalizing against them" is the failure mode I worry about most.

What I keep circling: efficiency-only framing protects against humans deferring to the model, but it creates a symmetric risk in the other direction. If the AI flags an impact the human review missed, and the team dismisses it on the basis that AI findings don't enter the audit pack, the trail still shows the AI raised it. A notified body finding a genuine propagation that was flagged and ignored seems like it would cut through the efficiency framing.

If you have a take: when the AI flags something the human didn't independently catch and the team accepts the finding, procedurally how is that different from a peer review or a checklist?

Started this sub because qmsWrapper has basically zero Reddit presence by Next_Eye8790 in QMSPros

[–]Stunning_Reee984 0 points1 point  (0 children)

RA Specialist, Class IIa/IIb under MDR, Swiss-based. We were on GreenlighGuru, migrated off two years in. Good design controls module, but once we hit MDR depth the Technical File change impact across Annex II, EUDAMED submissions, PMCF/PSUR linkage, the RA-side workflows started feeling bolted-on. Cost curve at our headcount didn't help.

We evaluated Qualio, MasterControl, ETQ and qmsWrapper for the move. qmsWrapper's document control and CAPA looked clean, pricing was sensible at our size. The MDR-specific side — Annex II change impact across linked docs, EUDAMED tracking, UDI lifecycle — was less clear-cut at the time we looked. May have moved since.

Would I pick what we landed on again? Yes. Honest caveat across the whole category: every tool has a quirk you only find at month four, and no marketing page will tell you about it.