Postmarket
Electronic Medical Device Reporting (eMDR) Software
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.
Let advanced eMDR software simplify your medical device reporting.
Digital eMDR Reporting Efficiency
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.
Faultless eMDR Documentation
MasterControl brings a structured workflow to your medical device reporting. All MDR event files are properly documented and digitally maintained in a central, secure system. The eMDR reporting solution makes it easy for users to record electronic submission dates. It also allows them to input the FDA’s email confirmations directly into the system.
Customer Complaint Tracking System
MasterControl eMDR software facilitates fast and thorough customer complaint handling. When a complaint form is filled out, the system can automatically initiate the population of specific fields based on triggers built into the complaint form. If follow-up is required, users can launch a new MDR form from the parent form. MDRs can also be manually generated within the eMDR reporting system.
Optimal Connectivity
Issues, descriptions of events and similar types of data often impact more than just medical device reporting. With the integrated MasterControl system, these data points can be set to automatically populate corresponding form fields. Our eMDR software seamlessly integrates MDR with quality and other core processes.
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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.
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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