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软件作为医疗器械:美国的要求和监管格局

Shivani Shah1, Priyanka Thakor1, Aakash Shah1

  • 1Diabetes, Medtronic MiniMed Inc., Northridge, CA, USA.

Expert review of medical devices
|September 14, 2025
PubMed
概括

监管框架对于人工智能 (AI) 和机器学习 (ML) 在软件作为医疗设备 (SaMD) 中的安全整合至关重要. 总产品生命周期 (TPLC) 方法对于管理基于AI/ML的SaMD风险和确保公平的创新至关重要.

关键词:
数字健康数字健康人工智能 (ai) 是一种人工智能.美国食品和药物管理局 (FDA)机器学习 (ml)软件作为医疗器械 (SaMD)

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