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医療機器としてのソフトウェア：米国における要件と規制状況

PMID: 40947420 · 2025-10-14

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学術誌Expert review of medical devices

年2025-10-14

PMID40947420

抄録

The integration of software into medical devices has profoundly transformed the healthcare landscape, enabling precise diagnostics, personalized treatment , and remote patient monitoring. The rapid pace of software development - especially with artificial intelligence (AI) and machine learning (ML) - demands regulatory frameworks to ensure patient safety, effectiveness, and reliability. Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independent

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