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 following 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
Quality assurance procedures and specifications, including acceptance criteria and the quality assurance equipment to be used;
Packaging and labeling specifications, including methods and processes, used; and
Installation, maintenance, and servicing procedures and methods.