Safety rules for AI medical devices leave four gaps, a review of 19 sources finds
A peer-reviewed review published August 13, 2026 examined how AI-enabled medical devices challenge traditional safety-risk management. Drawing on 19 academic and regulatory sources, it found ISO 14971, AAMI CR34971 and the EU AI Act each cover parts of device safety and algorithmic governance but remain fragmented in…
International Journal of Risk & Safety in Medicine
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