One NCR form to rule them all stopped working the day we added our 30th supplier
Last month, a buyer pinged me: "Why is this incoming-inspection NCR asking me whether the customer filed a complaint?" Fair question. It's because w…
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21 CFR Part 11 is where 'approve by email' shops quietly fail — a typed name is not a signature
The CAPA that taught me what an email isn't Two years ago I inherited a CAPA queue that included a finding from our prior notified body audit. The w…
The AI approval boundary nobody talks about until the audit finds it
The first time I saw an AI approve a CAPA closure, I'll admit I paused. Not because the decision was wrong — it wasn't — but because I couldn't find…
Чему нас научил опыт разработки и обеспечения безопасности IoT-устройств СберЗдоровья
В этой статье расскажем о медицинских IoT-устройствах медицинской компании СберЗдоровье, особенностях их разработки и способах обеспечения кибербезо…
Begin with control; the real win is turning it into daily practice
To be fair, "we have a QMS" is the easiest checkbox in a notified‑body audit. The hard part is that regulators, auditors and — most importantly — fr…
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…
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…