IMDRF document

Post-Market Clinical Follow-Up Studies

IMDRF Technical document · IMDRF/MDCE WG/N65FINAL:2021 (formerly GHTF/SG5/N4:2010) · posted May 20, 2021

Key facts

Title Post-Market Clinical Follow-Up Studies
Document reference IMDRF/MDCE WG/N65FINAL:2021 (formerly GHTF/SG5/N4:2010)
Issued by IMDRF
Document category Technical document
Posted May 20, 2021
IMDRF page imdrf.org
Document file imdrf.org

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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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