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The cleanest way to keep your compliance‑AI out of the EU AI Act high‑risk class: AI proposes, a human approves and signs

I nearly signed off on an "auto‑close" feature for an AI that triaged evidence requests. It would have saved the team hours a week. We didn't enable…

qmscomplianceregulatory
Dev.to Aug 25, 2026, 10:14 UTC
EN

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…

qmsmedtechcomplianceregulatory
Dev.to Aug 22, 2026, 15:11 UTC
EN

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,…

qmsmedtechcomplianceregulatory
Dev.to Jul 13, 2026, 19:06 UTC

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