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Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?
Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe. Recently, the Medical Device Regulation, which aims to set high standards of safety and quality, has become ap...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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SAGE Publications
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8977702/ https://www.ncbi.nlm.nih.gov/pubmed/35386955 http://dx.doi.org/10.1177/20552076221089079 |