![]() The Device History Record (DHR), on the other hand, is the demonstrable proof that you have followed that instruction manual as you have manufactured your device.Īn ‘instruction manual’ for manufacturing your medical device The Device Master Record (DMR) can be thought of as the definitive instruction manual for the compliant manufacture of your medical device, while the Design History File (DHF) is the complete record of the way that instruction manual was designed and compiled in the first place. What’s the difference between the DHF, DMR and DHR? ![]() They are the required collections of documents that medical device developers must assemble and make available to auditors to prove compliance, gain FDA approval, and market their devices in the US. DHF stands for Design History File, DMR stands for Device Master Record, and DHR stands for Device History Record. ![]() They are all abbreviations used by the FDA in their medical device quality regulation.
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