IMDRF · International guidance
IMDRF/SaMD WG/N41:2017
Software as a Medical Device (SaMD): Clinical Evaluation
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/N41:2017
- Published (source metadata)
- September 21, 2017
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About this guidance
Software as a Medical Device (SaMD): Clinical Evaluation
Clinical evaluation guidance for Software as Medical Device. Covers valid clinical association, analytical validation, and clinical validation.