IMDRF document
Reportable Events During Pre-Market Clinical Investigations
GHTF GHTF Study Group 5 - Clinical Safety/Performance · GHTF code: GHTF/SG5/N5:2012 · posted Aug 10, 2012
Key facts
| Title | Reportable Events During Pre-Market Clinical Investigations |
|---|---|
| Document reference | GHTF code: GHTF/SG5/N5:2012 |
| Issued by | GHTF |
| Document category | GHTF Study Group 5 - Clinical Safety/Performance |
| Posted | Aug 10, 2012 |
| 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: