PubMed

Software as Medical Devices: requirements and regulatory landscape in the United States.

PMID: 40947420 · 2025-10-14

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ZeitschriftExpert review of medical devices

Jahr2025-10-14

PMID40947420

Zusammenfassung

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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