IMDRF document

IMDRF Standard Operating Procedures

IMDRF Procedural document · IMDRF/MC/N2 FINAL:2021 (Edition 7) · posted May 21, 2021

Key facts

Title IMDRF Standard Operating Procedures
Document reference IMDRF/MC/N2 FINAL:2021 (Edition 7)
Issued by IMDRF
Document category Procedural document
Posted May 21, 2021
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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