IMDRF/SaMD WG/N12: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
Summary
Final Technical document
This document has been developed by the International Medical Device Regulators Forum (IMDRF) — a voluntary group of medical device regulators from around the world who work together to accelerate international convergence in medical device regulation.
Document Details
- Document Code: IMDRF/SaMD WG/N12
- Type: Technical document
- Issuing Authority: IMDRF
- Date: 2014-09-18
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Source: International Medical Device Regulators Forum (IMDRF). This content is provided for informational purposes. Always refer to the official IMDRF document for the most current version.
Document Details
Document IDIMDRF/SaMD WG/N12
TypeIMDRF Technical document
AuthorityIMDRF
Publication Date2014-09-18