What is a Device Master Record (DMR)?

Device Master Record Definition

A device master record (DMR) is a collection of records that contains the procedures and specifications for a finished medical device. According to the FDA quality system regulation, a device master record should include, or refer to the location of, the following items:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used
(d) Packaging and labeling specifications, including methods and processes used
(e) Installation, maintenance, and servicing procedures and methods

Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.181

What is a Device Master Record