Medical Device Reporting Software

Medical device reporting (MDR) is critical to compliance. Meeting the regulatory requirements for MDR, however, is always a challenge. And trying to do so with disparate systems only increases the difficulty. Electronic medical device reporting software makes compliance easier.

Any problems with or adverse events due to a medical device must be reported to the U.S. Food and Drug Administration (FDA) by the product’s manufacturer. The reporting guidelines for medical devices are outlined in regulation 21 CFR Part 803. MasterControl’s electronic medical device reporting (eMDR) software solution digitizes and streamlines device makers’ reporting processes and aligns them with regulatory guidelines.

MasterControl eMDR