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类别: DOCUMENTATION
器械主记录(DMR)
包含成品医疗器械程序和规格的记录汇编，包括器械规格、生产过程、质量保证程序和标签。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 器械主记录(DMR) across 27 authorities in real time.
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