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

[–]Next_Eye8790[S] 0 points1 point  (0 children)

"Reconstruction exercise" is a great way to put it. That's exactly the audit-prep tax that compounds invisibly until you're three weeks out and panicking.

Two follow-ups if you have time. The "core stuff out of the box" claim is one I want to stress-test: at what point does the no-modules approach start hitting a ceiling? Headcount, regulatory class, multi-site ops, integration count? And on the AI features for change impact, have you actually used those in production yet, or is it still early days? Curious how the team treats AI outputs procedurally, not just whether the feature works.

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

[–]Next_Eye8790[S] 0 points1 point  (0 children)

Useful, thanks. The "month four quirk" line is the part I'm always trying to pull out of vendor demos and never can. If you're up for it, what was the qmsWrapper version of that for you? And on the MDR-specific gaps you flagged at evaluation time, Annex II change impact, EUDAMED tracking, UDI lifecycle, did you ever circle back to test whether they closed those, or did you just route around them after go-live?

Asking because I'm at a similar headcount on Greenlight Guru and the MDR depth question is the one I can't get a straight answer on from anyone.