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Software as a Medical Device (SaMD): Key Definitions

Origin/Publisher:

IMDRF

Document Type:
Guidance
Content:
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical device and a reminder of other key terms, some previously defined in Global Harmonization Task Force (GHTF) documents, with relevance to SaMD.

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