Health and Safety Authority

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

Alan G. Fraser, Elisabetta Biasin, Bart Bijnens et al.

2023 · 56 Zit.

CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software

Frank Rademakers, Elisabetta Biasin, Nico Bruining et al.

2025 · 7 Zit.