The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on …

International Medical Device Regulators Forum (IMDRF) documents support the work of IMDRF members.

International Medical Device Regulators Forum (IMDRF) active working groups that are progressing current work tasks requested by the IMDRF Management Committee.

May 13, 2025 · Characterization Considerations for Medical Device Software and Software-Specific Risk 29 January 2025 Information document IMDRF/MC/N87

Nov 8, 2024 · Read the latest news and see the upcoming events for the International Medical Device Regulators Forum (IMDRF).

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establish IMDRF adverse event terminology including terms for medical device malfunction, evaluation result/conclusion, patient/user outcome, and part/component of a medical device

May 13, 2025 · IMDRF code: IMDRF/MC/N2FINAL:2025 (Edition 13 Version 2) Published date: 13 May 2025

Mar 3, 2025 · IMDRF/AE WG/N43 FINAL:2020 (below) is the guidance document outlining the concept behind the IMDRF Terminology including terms, definitions and IMDRF alpha …