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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 Nair3d ago • 4 min read
MDR reform (Dec 2025): what the new “breakthrough” pathways mean for small medtech teams
The reform package that circulated in December 2025 finally puts an explicit “breakthrough” or...
#medtech#regulatory#compliance
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Priya Nair3h 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 Nair3h 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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NevoSayNevo2d ago • 2 min read
Spain Blocks Polymarket and Kalshi: What the Global Regulatory Crackdown Means for Prediction Market Builders
Prediction markets like Polymarket and Kalshi have seen explosive growth, blending information...
#polymarket#kalshi#europe#regulatory
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