design master record design history file

Installation, maintenance, and servicing procedures and methods.

Each manufacturer shall maintain device master records (.) The DMR for each type of device shall include, or refer to the location of, the following information:.

This is where we find more data about the DMR.Ģ1 CFR 820.181 says (some text stripped): There is a section in the 21 CFR, which lists mandatory records for medical devices: 21 CFR part 820, subpart M - Records (sections 180 to 198).

any other document useful to the end-users, administrators, technical personnel, support personnel.īut the DMR is more than that.

the technical documentation (software requirements, design and tests, risks analysis.), output of the design process,.the software itself, binaires, scripts, configuration files and so on,.The scope of the design transfer should contain, depending of your software: It shall be based on the snapshot of the validated design. So a design transfer phase or review (or any other provision in your QMS) shall exist to prove that this design transfer actually happens. 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.

Design master record design history file