AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.
By EsqSocial Corporation 29/04/25
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the globe, frameworks such as the EU AI Act, ISO 13485 combined with the EU Medical Device Regulation (MDR), FDA’s regulatory pathways, and the U.S. Quality System Regulation (QSR) under 21 CFR Part 820 establish different expectations for AI-enabled devices. Understanding the...
By: Hogan Lovells