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.
Hundreds of medical device companies around the world use MasterControl to automate business processes. Learn why medical device industry leaders rely on solutions like the MasterControl eMDR system.
MasterControl ensures that the collection and submission of MDR data is always streamlined and timely. Our medical device reporting software lets you report to the FDA electronically, which helps save time and resources. Users can even create XML packets in the format specified by the FDA.
Our eMDR software features configurable standard reports. It lets users group MDRs by product or outcome type and provides totals and charts. The eMDR system builds summaries that provide the most relevant data for all MDRs. It even presents the most relevant data for MDRs awaiting acknowledgements. Elapsed time between event and report dates (and an average time for all MDRs) is also available.