IMDRF · International guidance

IMDRF/SaMD WG/N12:2014

Software as a Medical Device: Risk Categorization Framework

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/N12:2014
Published (source metadata): September 18, 2014

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About this guidance

Software as a Medical Device: Risk Categorization Framework

Framework for SaMD risk categorization based on healthcare situation and significance of information. Foundation for global SaMD regulation.