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评估欧盟人工智能法案对医疗器械监管的影响

Konstantinos Kalodanis1, Georgios Feretzakis2, Panagiotis Rizomiliotis1

  • 1Department of Informatics & Telematics, Harokopio University of Athens, Kallithea, Greece.

Studies in health technology and informatics
|April 9, 2025
PubMed
概括

欧盟人工智能法对医疗器械法规产生了影响,给人工智能系统带来了合规性挑战. 将人工智能法与医疗器械法规等现有框架协调一致,对于安全的创新至关重要.

关键词:
"人工智能法"是"人工智能法案".这是一个IVDR,IVDR是IVDR.在MDR中使用MDR.符合合规性的合规性是什么医疗器械 医疗器械 医疗器械风险管理 风险管理

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