DMR
A term from the former Quality System Regulation (21 CFR 820.181) for the records holding a device's specifications, production, quality, labeling and servicing procedures. The QMSR replaced it with the ISO 13485 medical device file.
A term from the former Quality System Regulation (21 CFR 820.181) for the records holding a device's specifications, production, quality, labeling and servicing procedures. The QMSR replaced it with the ISO 13485 medical device file.