Tuesday, January 7, 2014
IMDRF targets uniform standards for medical device auditors
IMDRF targets uniform standards for medical device auditors-massdevice: The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.