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

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

Abstract The European CORE–MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical p...

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Main Authors: Frank E. Rademakers, Elisabetta Biasin, Nico Bruining, Enrico G. Caiani, Rhodri H. Davies, Stephen H. Gilbert, Eric Kamenjasevic, Gearóid McGauran, Gearóid O’Connor, Jean-Baptiste Rouffet, Baptiste Vasey, Alan G. Fraser
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01459-8
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https://doi.org/10.1038/s41746-025-01459-8

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