EU AI Act compliance

EU AI Act vs FDA SaMD Compliance: 7 Critical Wins

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Let me be direct: EU AI Act vs FDA SaMD compliance is the most consequential dual-regulatory challenge facing digital health startups right now. Not eventually. Right now, in 2026, with the AI Act’s high-risk provisions fully operative. FDA’s Predetermined Change Control Plan (PCCP) guidance is simultaneously reshaping how machine-learning-enabled devices are reviewed on the US … Read more

QMSR Transition Success: The Definitive FDA 21 CFR 820 & ISO 13485 Guide (2026)

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QMSR Transition: Harmonizing FDA 21 CFR 820 with ISO 13485:2016 — Post-Implementation Guide 2026 A post-implementation compliance and inspection readiness guide for medical device manufacturers — April 2026 Updated April 2026 | 18-minute read | FDA QMSR, ISO 13485:2016, CP 7382.850, ISO 14971 risk management Table of Contents The Day the QSR Died — How … Read more