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.
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.
MasterControl has been easing companies’ compliance burdens since 1993. Our medical device quality management systems are purposefully designed to meet regulations like 21 CFR Part 803. And our experts have a proven track record of helping electronic medical device manufacturers implement and manage eMDR systems and related processes.
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