Once manufacturing begins, each individual device manufactured will also maintain a Device History Record.Posted by Bob Duffy on Octoin Device Tips, Manufacturingĭesign History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR 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.
Contrary to the DHF, the DMR is a snapshot of a software version.ĭMRs must be maintained. 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. 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. The Technical Documentation output from the DHF Installation Procedures/Methods, Information for User (IFU) Packaging and Labeling Specifications (including all methods and processes employed) Production Process Specifications (including equipment specifications, production methods, production procedures, and production environment specifications. 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, includingĭevice Specifications (including all applicable drawings, composition and formulation) The DMR is a comprehensive record of all the procedures, instructions and specifications required to manufacture a device.
With transfer to manufacturing from design and development, the Device Master Record (DMR) takes over from the Design History File (DHF). Establishing and Maintaining the Device Master Record
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