IMDRF document
Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices…
IMDRF Information document · IMDRF/MC/N37 FINAL:2015 · posted Oct 2, 2015
Key facts
| Title | Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" |
|---|---|
| Document reference | IMDRF/MC/N37 FINAL:2015 |
| Issued by | IMDRF |
| Document category | Information document |
| Posted | Oct 2, 2015 |
| 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: