What Is Device Master File

What Is Device Master File

A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.

What is the purpose of a device master record?

The main purpose of the device master record is to centralize a record of the production process in a way that distinguishes it from the design process.

What is the difference between design history file and device master record?

In simple terms, a DHF (Design History File) marks the start of a particular device and documents how an OEM arrived at the final design. A DMR (Device Master Record) details the specific material, equipment, and environment requirements for production.

James H. Sterling
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James H. Sterling

James Sterling reports on renewable energy developments, climate policy, ecological conservation, and green tech innovations around the globe.