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 engi…
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Where usability files actually break — and what I do about it
I stopped treating the usability file as a compliance artifact years ago — it’s where product design and real people collide. When it’s done badly,…
Why our eQMS ran in parallel for 18 months — and what I’d do differently
I’ve been responsible for maintaining a Class II product’s QMS during one of the messiest migrations I’ve seen: an 18‑month parallel run where the o…