Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. The DMR contains the output of the design transfer. This is one practical reason that DMR is required for all medical device software, whichever their class. Especially for medical device software (standalone or embedded) production controls always apply. Production controls apply to (almost) all medical devices of any classes. The DHF contains all the design history, the DMR contains the snapshot of the device specifications validated at the end of the design phase. The DMR is used during the production phase. The DHF, this is in its name, covers the design phase. The difference resides in the phase of the product lifecycle covered by these concepts. Can you see the difference with the Design history file? Like the DHF, the DMR applies to a finished device.īut the DMR is the Device master record. Device master record means a compilation of records containing the procedures and specifications for a finished device.The section 21 CFR 820.3(j), gives the definition of DMR: You can find it in the online copy of 21 CFR on the FDA website. The DMR is a term defined by the US regulations.
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