Regulatory Pathway and Evidence Requirements for Clinical Artificial Intelligence as Medical Device Software (MDSW/SAMD) Under the MDR And the AI Act.
- International Clinical Pathology Journal
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Marco Viscovo,<sup>1</sup> Marcella Marletta,<sup>2 </sup>Roberto Verna<sup>1,2,3</sup>
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Keywords
artificial intelligence; medical device regulation; software as a medical device; clinical validation; risk management; post-market surveillance
