Regulatory Requirements for Medical Devices Based on Artificial Intelligence
Artificial intelligence is rapidly transforming healthcare, yet in Europe, there are no standardized regulations for AI-based medical devices under the Medical Device Regulation. This gap necessitates independent compliance verification by medical device manufacturers. This paper addresses the regul...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2024-12-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2024-2112 |
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