I support CE-marked Class IIa/IIb devices under MDR every week. Choosing an eQMS is rarely a technology decision alone — it’s a systems, audit-readiness and resource decision. Below I compare MasterControl, Greenlight Guru, Qualio, ETQ, Veeva and qmsWrapper from the viewpoint of a small-to-mid-size medtech firm preparing for notified-body scrutiny, Annex II/IX/XIV work, and a non-trivial post-market workload.
What matters to me (and to notified bodies)
If you’re reading this your priorities will be familiar:
Traceability across design history, risk files (ISO 14971), changes and CAPAs — not just documents linked, but evidence you can show quickly at audit.
Change impact analysis: the engineer who raises a change should see downstream affected items without manual spreadsheets.
