IMDRF document

Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for…

IMDRF Information document · IMDRF/MC/N25 FINAL:2015 · posted Apr 7, 2015

Key facts

Title Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects - Good clinical practice"
Document reference IMDRF/MC/N25 FINAL:2015
Issued by IMDRF
Document category Information document
Posted Apr 7, 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:

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