IMDRF document

Machine Learning-enabled Medical Devices: Key Terms and Definitions

IMDRF Technical document · IMDRF/AIMD WG/N67 · posted May 9, 2022

Key facts

Title Machine Learning-enabled Medical Devices: Key Terms and Definitions
Document reference IMDRF/AIMD WG/N67
Issued by IMDRF
Document category Technical document
Posted May 9, 2022
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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