Published July 2026 | Practical guidance for medical-device founders, QA/RA leaders, software teams, and AI governance owners. ISO 42001 vs ISO 13485 is not a choice between two competing quality standards. ISO 13485:2016 is the regulated medical-device quality management system backbone. ISO/IEC 42001:2023 is an organization-wide artificial intelligence management system standard that adds governance for … Read more
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: 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
