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IAF MD 9:2022 – Changes in Medical Device Quality Management Systems

Hospital hallway with medical devices following ISO 13485 quality management and accredited with IAD MD 9:2022 requirements.

IAF MD 9:2022, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems specifies normative criteria for conformity assessment bodies (CABs) auditing and certifying organizations’ Quality Management Systems to ISO 13485, in addition to the requirements contained in ISO/IEC 17021-1. IAF MD 9 was revised and published in February 2022. The IAF Medical Device work group has recommended a 2-year transition period. The changes are only applicable to certification bodies.

Changes in IAF MD 9:2022

The major changes in IAF MD 9:2022 include:

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