Device Master Record

Device master record (DMR) is the term used in the Quality System (QS) regulation for all of the routine documentation required to manufacture devices that will consistently meet company requirements. Section 820.3(j) of the QS regulation defines device master record as a compilation of records containing the procedures and specifications for a finished device. The DMR for each type of device shall include, or refer to the location of, the following information:

1. Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
2. Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
3. Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
4. Packaging and labeling specifications, including methods and processes used; and
5. Installation, maintenance, and servicing procedures and methods.

In addition to the device specifications, a device master record contains documents that cover typical manufacturing activities such as:

• procurement,
• assembly,
• labeling,
• test and inspection,
• packaging, and
• where applicable, sterilization.