Device Master Record (DMR)

Device Master Record (DMR) is the FDA-mandated compilation of all the information required to manufacture a finished medical device — the manufacturing recipe of record. It is the controlled, released set of specifications, procedures, BOMs, work instructions, packaging, and labeling that production must follow exactly.

What it covers

• Device specifications — drawings, components, and formulation.
• Production process specifications — manufacturing routings and work instructions.
• Quality assurance procedures — incoming inspection, in-process controls, finished-device acceptance.
• Packaging and labeling specifications including UDI requirements.
• Installation, maintenance, and servicing procedures when applicable.

Relationships (see sidebar)

• Conforms to 21 CFR Part 820 §820.181 and ISO 13485 §4.2.3 (medical device file).
• Supports Manufacturing Execution, Release Management, and Regulatory Submission.
• Implemented by medical-device PLM/QMS platforms including Aras Innovator, PTC Arena, and PTC Windchill.
• Pairs with the Design History File (design evidence) and Device History Record (per-unit production evidence).