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DisclosureProof6d ago • 7 min read
I built a scanner to check whether EU chatbots admit they're bots. It kept catching me instead.
Article 50 of the EU AI Act is the short, human-sized part of a very long law. If a visitor is...
#webdev#ai#eu#regulatory
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Priya Nair6d ago • 4 min read
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...
#qms#compliance#regulatory
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Priya Nair19h ago • 4 min read
If your QMS SaaS has EU users, the EU AI Act may apply to you — location matters more than HQ
I run regulatory work for devices under EU rules; I see the same jurisdictional lesson repeating wit...
#qms#compliance#regulatory
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James Whitfield4d ago • 4 min read
Skeptical pause: foundation models aren’t a plug‑and‑play for regulated QMS
I’ve been in quality/regulatory 14 years, and over the last 18 months I’ve seen two parallel...
#qms#medtech#compliance#regulatory
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James Whitfield5d ago • 4 min read
A lean, audit-ready path for tight timelines — what to do in 8 weeks
I watched this short walkthrough (linked below) and built a practical, time-boxed plan from it that....
#qms#medtech#compliance#regulatory
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James Whitfield4d ago • 4 min read
Bake audit‑readiness into daily work: map SOPs, verify links, and automate approvals
I stopped treating "audit prep" as a quarterly fire drill two years ago. We're a 200‑person Class II...
#qms#medtech#compliance#regulatory
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James WhitfieldAug 25, 2026 • 4 min read
Why that rushed draft disappeared — and how a controlled form made the owner (and the deadline) visible
A rushed change-request or CAPA draft doesn’t get forgotten because people are lazy — it disappears....
#qms#medtech#compliance#regulatory
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Priya Nair5d ago • 4 min read
Miss a PSUR and your surveillance close‑out can stall — who’s actually tracking your calendar?
Miss your PSUR and the notified body will notice. I don’t mean a gentle nudge — I mean surveillance....
#qms#medtech#regulatory
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