Tech
Picking an eQMS for a 200-person Class II device shop — a pragmatic comparison
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 th...
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