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James Whitfield3d ago • 4 min read
How MDR vs IVDR changes the CAPA game (and what I actually changed in our QMS)
I’ve managed CAPA and change-control for Class II-ish devices through MDR audits, and the IVDR...
#qms#medtech#compliance#regulatory
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Priya Nair2h ago • 4 min read
How I validate LLMs for GxP work — scope, evidence, and the auditor's checklist
I started seeing LLMs in the quality workflows at my company two years ago. At first it was hobbyist...
#qms#medtech#compliance#regulatory
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Priya Nair2h ago • 3 min read
Interoperability and connectivity: practical compliance for connected medical devices
I’ve owned the regulatory side of several Class IIa/IIb connected devices. The technical novelty...
#qms#medtech#compliance#regulatory
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