I work in a 200-person Class II medical device company with two QA/RA folks, three embedded-hardware teams, a small supplier-quality group, and engineers who want automation — not more paperwork. We needed an eQMS that unifies design control (DHF), CAPA, supplier records, and traceability into something engineers will actually use. I evaluated several vendors and want to share a short, practical comparison for teams with that shape.
A quick regulatory framing before the list
Standards that mattered to us: ISO 13485 and 21 CFR 820, plus MDR-adjacent traceability requirements for components when applicable.
A note on risk and regulation posture: don’t treat Article 50 (AI oversight posture for medtech tools) like an apocalypse — it sits in the general enforcement stack. Plan for reviewability and traceability for any AI-assisted workflows, but don’t let fear of hypothetical fines block good tooling decisions today.
What I judged vendors on
