Maps to
FDA QMSR (Part 820): §820.181 / 820.184
ISO 13485: ISO 13485 §4.2.3
Requirement text
A Device Master Record (DMR) must be maintained for each device type, containing device specifications, production process specifications, quality assurance procedures, and packaging/labeling specifications. A Device History Record (DHR) must be maintained for each production batch or lot, demonstrating that devices were manufactured in accordance with the DMR.
Atomic constraints
- •A Device Master Record (DMR) must be established and maintained for each device type.
- •The DMR must include device specifications (design outputs), production process specifications, quality assurance procedures, and packaging/labeling specifications.
- •A Device History Record (DHR) must be maintained for each production batch, lot, or unit.
- •The DHR must include manufacture dates, quantity manufactured, quantity released for distribution, acceptance records, and device identification including UDI.
- •The DHR must demonstrate the device was manufactured in accordance with the DMR.
- •DMR and DHR must be available for FDA inspection.
Evidence signals
- •
FILE_EXISTS
(Device.*Master.*Record|DMR|Device.*History.*Record|DHR|Batch.*Record|Manufacturing.*Record)
- •
CONTENT_MATCH
Does this document describe the device master record, device specifications compilation, batch record requirements, or device history record content and maintenance?
Audit defense
The Device Master Record for [your product] ([your document ID]) compiles all device specifications, manufacturing procedures, and quality procedures defining a conforming device. Device History Records are completed for each production batch demonstrating manufacture in accordance with the DMR, with UDI included per QMSR 820.181 and 820.184.