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IMDRF Issues Proposed Guidances On Device Auditors, Global UDI System

The International Medical Device Regulators Forum issued proposed guidance documents on monitoring of device auditing organizations, training for auditors and core elements of a global UDI system.

The International Medical Device Regulators Forum released three draft guidance documents addressing the recognition and monitoring of device auditing organizations, minimum competency and training requirements for auditors, and the core elements of a globally harmonized unique device identification system.

The documents were posted on the group’s website

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