IMDRF document
Characterization Considerations for Medical Device Software and Software-Specific Risk
IMDRF Technical document · IMDRF/SaMD WG/N81 FINAL:2025 · posted Jan 29, 2025
Key facts
| Title | Characterization Considerations for Medical Device Software and Software-Specific Risk |
|---|---|
| Document reference | IMDRF/SaMD WG/N81 FINAL:2025 |
| Issued by | IMDRF |
| Document category | Technical document |
| Posted | Jan 29, 2025 |
| IMDRF page | imdrf.org |
| Document file | imdrf.org |
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About IMDRF and GHTF documents
IMDRF is a forum of medical device regulators that writes harmonised guidance, such as the MDSAP audit documents and the UDI, SaMD and adverse-event terminology documents. It also hosts the archived documents of its predecessor, the Global Harmonization Task Force (GHTF).
Source: International Medical Device Regulators Forum (IMDRF), including the archived documents of the Global Harmonization Task Force (GHTF) · Source date: