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tme3 replied to the topic DHF vs. DHR in the forum Device Documentation 8 years, 2 months ago
As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintains manufacturing, sterilization, QC as well as produced quantities of any specific lot number of 1 time use medical devices or the complete traceability of implants and multi-use medical devices.