MDR

ISO 42001 vs ISO 13485: How to Build an AI Medical Device QMS

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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

The Critical EU MedTech Innovation Pressure: Navigating 2026 MDR & EY-DG SANTE Updates.

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The EU MedTech Innovation Pressure: Navigating 2026 “Crunch” and EY-DG SANTE Findings For years, the European Union was the global launchpad for EU MedTech Innovation, but recent data suggests a pivotal identity crisis is looming. A “CE Mark” was often the first major milestone for a startup before tackling the FDA. However, the tide has … Read more