IMDRF · International guidance
IMDRF/SaMD WG/N23:2015
Software as a Medical Device (SaMD): Application of Quality Management System
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/N23:2015
- Published (source metadata)
- October 2, 2015
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About this guidance
Software as a Medical Device (SaMD): Application of Quality Management System
QMS guidance specific to SaMD including software lifecycle, configuration management, and problem resolution.