IMDRF · International guidance
IMDRF/SaMD WG/N81:2025
Software-Specific Risk Characterization for Medical Device Software
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/N81:2025
- Published (source metadata)
- January 29, 2025
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About this guidance
Software-Specific Risk Characterization for Medical Device Software
Characterization considerations for medical device software and software-specific risk assessment. Covers intended purpose, algorithm design, and clinical context.