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 |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-02-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01459-8 |
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