Electronic Medical Device Reporting (eMDR) Software Systems

Electronic Medical Device Reporting (eMDR) Software Systems for Electronic Automation of Medical Device Reporting and for Compliance with Other Global Regulatory Environments

The FDA’s medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries as well as certain malfunctions associated with their devices. MasterControl Inc. offers an electronic medical device reporting (eMDR) software solution that enables MasterControl users to implement their FDA adverse event reporting process electronically.

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How MasterControl Makes Medical Device Reporting Easier with Electronic Medical Device Reporting Systems

The MasterControl's eMDR systems has been designed to meet the requirements for forms processes within the confines of FDA/GxP environments including compliance with 21 CFR Part 11. Here’s how MasterControl eMDR helps companies address challenges that are common to the implementation and management of MDR systems:

  • With MasterControl eDMR software, all MDR event files are adequately documented and electronically maintained in a centralized, secure repository.
  • Reporting to FDA electronically is efficient, saving time and resources. MasterControl’s automated system ensures that reporting and submission of MDR data is timely and consistent.
  • MasterControl forms keep MDR reporting consistent and in line with regulatory requirements. The system also maintains a summary log of the types of events that have and haven’t been reported.
  • MasterControl connects all MDR decision makers, ensuring that information travels through the proper channels.
  • MasterControl's electronic medical device reporting software systems facilitate rapid and thorough handling of customer complaints. With MasterControl, adverse events can be reported quickly and consistently.

Features and Benefits of eMDR Software

  • Robust Reporting Capabilities: MasterControl eMDR software features customizable standard reports. The types of useful reports provided by the system include:
    • Medical Device Reporting Summary: Presents the most relevant data for all MDRs.
    • Medical Device Reporting by Product: Groups MDRs by brand name.
    • Medical Device Reporting by Outcome: Complete with charts and number count for each type of outcome.
    • Medical Device Reporting Awaiting Acknowledgments: Presents the most relevant data for all MDRs awaiting one or more acknowledgments.
    • Medical Device Reporting Time to Report: Presents the time elapsed between the date of event and date of report with an average time for all MDRs.
    • Medical Device Reporting One-Year Trend: Includes a trending chart showing the number of MDRs over the preceding 12-month period.
  • Automatic Launch: When a complaint form is filled out, an eMDR system can be electronically initiated with appropriate fields automatically populated based upon certain triggers in the complaint form. In cases where follow-up is required, authorized users can launch a new MDR form from the parent form. MDRs can also be manually generated.
  • Connected, Highly Visible System: MasterControl provides a structured MDR workflow. All designated users can review MedWatch form sections and MedWatch instruction pages are easily accessible.
  • Optional Creation of an XML file for electronic submission to FDA: MasterControl allows users to generate XML packets in the format specified by the FDA.
  • Effective Data Collection: MasterControl users can record the electronic submission date in the electronic medical device reporting software and add e-mail confirmations from the FDA Electronic Submission Gateway (ESG) directly into the system.
  • Integration with Document Control and Other MasterControl Solutions: MasterControl eMDR seamlessly integrates with the document control system and other MasterControl applications that are useful in conjunction with the eMDR solution, including MasterControl Process™, MasterControl Documents™, and MasterControl PDF Publishing™.
  • Field Mapping from MasterControl Customer Complaints MD™: Information entered into MasterControl Customer Complaints MD (such as descriptions of events or problems) can automatically populate appropriate eMDR form fields.

Contact MasterControl for Electronic Medical Device Reporting Software Systems

Whether you are looking to learn more about eMDR software systems or MasterControl’s innovative GxP solutions, the MasterControl team can answer your questions. Call 800-825-9117 or contact MasterControl online.