Sparta Systems Inc., the maker of TrackWise software, has outlined recommendations to help companies prepare for electronic Medical Device Reporting (eMDR) regulations.

1. Thought - Before any system can be designed, a self-evaluation is required for companies to understand the scope and nature of their businesses' eMDR needs. Initially considering vital questions will lay the foundation for a successful transition before any planning or design has been implemented.
2. Planning - After the current MDR methodology has been reviewed and a needs-analysis has been conducted, the next step is to plan the transition from the old system to the new one. During this review, common processes should be leveraged and divergent processes isolated and documented. At the end, the actual method and means of receiving, transmitting, and auditing data are critical.
3. Design - Design of an eMDR system should bring together all the elements discussed and reviewed throughout the thought and planning phases. Designing an effective system that includes these elements working in proper order and alignment will result in reduced time and costs spent testing and, finally, implementing the final eMDR solution.
4. Testing - Once a system has been designed that will theoretically satisfy eMDR requirements, the next step is to test it. Possible failure scenarios should also be tested to ensure that the appropriate action takes place in the system when the failure is identified.
5. Implementation - Finally, when all the necessary steps have been completed, and the system has been thoroughly tested, implementation can occur. Careful observation of eMDR users and approvers is important to ascertain that they are adhering to correct procedures and that reports are being submitted and filed in a timely manner.

Sparta Systems says it has been in close communication with the FDA as the proposed legislation has been refined, and wants to provide its customers with an enterprise-wide quality management system that allows for a seamless transition from the current paper-based system to an electronic submission model. The company says the suggestions for eMDR compliance will not only help reduce associated compliance costs, but should also serve to streamline manufacturing processes, and help ensure the safety of medical devices. To learn more about eMDR and receive thorough preparation guidelines, click here.