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Electronic Medical Device Reporting | MasterControl

Electronic Medical Device Reporting (MDR)

The FDA’s medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries as well as certain malfunctions associated with their devices. MasterControl Inc. offers an electronic medical device reporting (eMDR) software solution that enables MasterControl users to implement their FDA adverse event reporting process electronically.