← All terms
CATEGORY: DOCUMENTATION
Device Master Record (DMR)
A compilation of records containing the procedures and specifications for a finished medical device, including device specifications, production processes, quality assurance procedures, and labeling. Required by FDA 21 CFR 820.181.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
The Device Master Record (DMR) is the approved set of documents that defines how a device is manufactured, labeled, packaged, and tested—the “recipe” for production.
PROCESS / STEPS
- Compile device specifications, drawings, BOM, production methods, acceptance criteria, and labeling artwork.
- Control changes via change control; train production to current DMR revision.
- Align DMR with design outputs transferred from DHF.
- Use DMR as the standard against which each DHR is released.
EXAMPLES
- DMR for a Class II monitor includes PCB assembly instructions, firmware version, packaging configuration, and IFU part numbers.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Device Master Record (DMR) across 27 authorities in real time.
START FREE →