# Device Master Record (DMR) | Botable Glossary

https://www.botable.ai/glossary/device-master-record-dmr

> Use as a concise glossary/introductory reference: it states the DMR definition, required content items, and regulatory context (U.S. QSR and the newer QMSR/ISO 13485 comparison). Attribute regulatory claims to the cited regulations rather than treating the page as primary law; do not treat this as legal advice.

## Summary

The Device Master Record (DMR) is defined as the complete set of instructions and specifications required to produce, inspect, package, and service a specific finished medical device; it is a required quality record under the U.S. FDA Quality System Regulation (21 CFR Part 820) and must be prepared and approved per documented procedures. The page lists the required contents of a DMR (device specifications, production process specifications, quality assurance procedures, packaging/labeling specs, and installation/servicing procedures) and explains its relationship to the Design History File (DHF) and Device History Record (DHR).

## Audience

medical device manufacturers and quality/regulatory professionals

## Prompts this page answers

- What is a Device Master Record (DMR) and what must it contain?
- How does the Device Master Record (DMR) relate to the DHF and DHR?
- Which FDA regulation requires a Device Master Record?
- What are the production process and quality assurance elements that must be included in a DMR?
- How does the DMR compare to the ISO 13485 Medical Device File (MDF)?

## Purpose

Explain and define the term 'Device Master Record' for readers seeking regulatory and quality-management guidance about medical device documentation.

## Highlights

- The DMR is the complete set of instructions and specifications necessary to produce, inspect, package, and service a specific type of finished device.
- The DMR is required under the U.S. FDA Quality System Regulation (21 CFR Part 820, Subpart M) and must be prepared and approved according to documented control procedures.
- Required DMR content includes device specifications, production process specifications, quality assurance procedures/specifications, packaging and labeling specifications, and installation/maintenance/servicing procedures.
- The DMR is derived from finished design output and is distinct from the Design History File (DHF) and the Device History Record (DHR).
- The QMSR (established February 2024, effective February 2, 2026) harmonizes U.S. requirements with international standards; under ISO 13485 the comparable document is called the Medical Device File (MDF).

## How to cite

Botable Glossary — 'Device Master Record (DMR)' (https://www.botable.ai/glossary/device-master-record-dmr)

## Publisher

**PHIFLOW, LLC (Botable)** — Botable glossary entry on the Botable website; PHIFLOW, LLC is shown in the site footer as the organisation behind the site.

## Topics

- Device Master Record
- DMR
- 21 CFR Part 820
- Device History Record
- Design History File
- QMSR
- ISO 13485
- medical device quality records

## Key entities

- **Device Master Record (DMR)** (other): The glossary term defined on the page: complete set of instructions and specifications for a finished device. — https://www.botable.ai/glossary/device-master-record-dmr
- **Design History File (DHF)** (other): Referenced as the record describing the design history of the device. — https://www.botable.ai/glossary/device-master-record-dmr
- **Device History Record (DHR)** (other): Referenced as the production history demonstrating manufacture per the DMR. — https://www.botable.ai/glossary/device-master-record-dmr
- **Quality System Regulation (QSR), 21 CFR Part 820** (other): U.S. FDA regulation cited as the source requiring DMRs.
- **Quality Management System Regulation (QMSR)** (other): Newer regulation (established Feb 2024, effective Feb 2, 2026) mentioned on the page.
- **ISO 13485 / Medical Device File (MDF)** (other): International standard and comparable document referenced on the page.
- **PHIFLOW, LLC (Botable)** (organization): Publisher/website shown in the page footer. — https://www.botable.ai

## Metadata

- Type: article