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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Traceability matrices die when treated as documents — how to keep traceability living
I used to maintain a traceability matrix as a 30‑row table in a Word document. It looked tidy on a submission day and then rotted quietly for the ne…
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,…
Picking an eQMS for an EU medtech SME — practical pros and cons of six vendors
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-readi…
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…