Establishing and Maintaining the Device Master Record
With transfer to manufacturing from design and development, the Device Master Record (DMR) takes over from the Design History File (DHF). The DMR is a comprehensive record of all the procedures, instructions and specifications required to manufacture a device. The DMR is used during the production phase of the device, and contains the snapshot of the device specifications validated at the end of the design phase, including
Device Specifications (including all applicable drawings, composition and formulation)
Component Specifications
Software Specifications
Production Process Specifications (including equipment specifications, production methods, production procedures, and production environment specifications.
Quality Assurance Procedures
Packaging and Labeling Specifications (including all methods and processes employed)
Installation Procedures/Methods, Information for User (IFU)
Maintenance Procedures and Methods
Servicing Procedures and Methods
The Technical Documentation output from the DHF
It is acceptable for the DMR to be a pointer document that identifies all the DMR documents and their locations for manufacturing and servicing a device.
Regarding software, DMR contains all information about a software version: set binaries or files used at runtime, set of documents, instructions, procedures to install, use, maintain, support, service it. Contrary to the DHF, the DMR is a snapshot of a software version.
DMRs must be maintained. For example, there must be a change package to account for each component change, process change, and for any other changes used to manufacture the finished medical device; these change packages must make it into the DMR. Once manufacturing begins, each individual device manufactured will also maintain a Device History Record.
