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;