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, th…
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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-readine…
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 old…