Medical Device Reporting (MDR)

The management of medical device reporting (MDR) processes is essential for compliance with FDA regulations and equally essential for good business practice and improvement.

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MasterControl Software Solutions for Medical Device Reporting

MasterControl recognizes that the essence of medical device reporting management is controlled MDR data, the ability to track status, and streamlined quality processes. The MasterControl Process solution, for example, provides data control and reporting while simultaneously streamlining quality processes by providing the following features and benefits:

  • MDR Forms (e.g., Medwatch Form 3500A) that can be populated electronically and automatically routed to pre-approved viewers/approvers.
  • Electronic MDR forms can provide fields with drop-down menus for easy selection of common information, making data entry faster and more accurate.
  • Industry standard Adobe PDF forms design platform simplifies printing and provides a familiar interface to users.
  • Automatically generates audit trails that can be useful during audits, etc.
  • Optional configuration with the MasterControl Customer Complaints and MasterControl CAPA solutions both of which can automatically generate a task for the completion and approval of an MDR if warranted.

MasterControl Medical Device Reporting Services

MasterControl provides the following services:

  • Implementation
  • Training
  • Technical Support
  • Validation
  • Project Management

For More Information on Medical Device Reporting

To learn more about the software solutions that can streamline medical device reporting (MDR) processes, please feel free to contact a MasterControl representative.