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Electronic Medical Device Reporting (eMDR) 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™
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Let advanced eMDR software simplify your medical device reporting.

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Digital eMDR Reporting Efficiency

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Faultless eMDR Documentation

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Customer Complaint Tracking System

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Optimal Connectivity

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Robust Reporting Capabilities

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.

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Streamlined Compliance

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. 

Medical device reporting doesn’t have to be a pain.

Optimize your processes with eMDR software.

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