DMR and medical device file

The device master record is the set of procedures and specifications for producing a device. ISO 13485 calls the related content a medical device file.

Historically, 21 CFR 820.181 described the device master record as the compilation of records containing the procedures and specifications for a finished device. ISO 13485:2016 clause 4.2.3 requires a medical device file for each device type or family, containing or referencing the documents that define the product specifications and the QMS requirements for that device, including labeling, servicing if applicable, and the installation and maintenance specifications.

People mix the DMR up with the DHF and the DHR. The DHF shows you designed it. The DMR or medical device file shows how to build and label it. The DHR shows you built a specific unit or lot that way. QMSR does not erase the need for those three ideas even as the regulation text points at ISO 13485.

Controlled procedures and specifications in HAVGATE document control are where the recipe should live if you want revision control. The module is not a manufacturing execution system.