IMDRF · International guidance
IMDRF/SaMD WG/N10:2013
Software as a Medical Device (SaMD): Key Definitions
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- IMDRF
- Reference
- IMDRF/SaMD WG/N10:2013
- Published (source metadata)
- December 18, 2013
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Software as a Medical Device (SaMD): Key Definitions
Key definitions for Software as Medical Device. Foundation terminology document distinguishing SaMD from SiMD.