What IMDRF SaMD Risk Framework requires
The IMDRF Software as a Medical Device (SaMD) Risk Categorization Framework provides a globally harmonized method for classifying the risk of independent medical software. It categorizes SaMD into four levels (I, II, III, IV) based on the criticality of the clinical situation and the impact of the information provided by the software on patient care.
Pillar: Medical & Healthcare · Authority: International Medical Device Regulators Forum (IMDRF) · Version: 1.1.0 · Last updated:
Primary source: https://www.imdrf.org/working-groups/software-medical-devices-samd
SHA-256 integrity: 3a27efc6051156b87cba811a17cccf22e7c4ba5f92e9b96d41bc162c59c5da19
Primary Citations — 6 traced to source
- IMDRF/SaMD WG/N12FINAL:2014 - Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
- IMDRF/SaMD WG/N10FINAL:2013 - Software as a Medical Device (SaMD): Key Definitions
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