Device master record.

§ 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.