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IMDRF inviting comments on Audit Program and UDI

Ajit Basrur

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International Medical Devices Regulators Forum (IMDRF) is inviting comments on Audit Program and Unique Device Identification (UDI) guidelines -

http://imdrf.org/consultations/consultations.asp

Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers

Recognition and monitoring of organizations undertaking audits of medical device manufacturers

UDI System for Medical Devices

The comments on first 2 are requested by Jun 14, 2013 while comments on UDI document requested by 31 Jul 2013.

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