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; and
(e) Installation, maintenance, and servicing procedures and methods.

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