Medical device dmr index
Simply put, device master record (DMR)is acollection of all the documents required to manufacture and test a medical device. The need to maintain DMR DMR is a part of the Quality System Regulation (QSR) of FDA to maintain standards in the manufacture and maintenance of medical equipment. The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which deals with record-keeping requirements for medical device companies. The device master record contains all of the information needed to produce the medical device from beginning to end.