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

FAQs

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

DMR content is being added. Stay tuned.

What must the device master record 21 CFR 820.181 include?

DMR content is being added. Stay tuned.

What is DMR in engineering?

DMR content is being added. Stay tuned.

What goes in the device master record?

DMR content is being added. Stay tuned.

READ OUR NEW

Software Buying Guide

Read the step-by-step guide to evaluate and buy the best software for your business.

Try Our New

Cost of Mistakes Calculator

Select your inputs, specific challenges, and calculate the estimated cost impact.