Electronic medical device reporting (eMDR) is an efficient method of submission developed by the Center for Devices and Radiological Health (CDRH) at the FDA. Top medical device manufacturers, distributors, and reprocessors have implemented automated eMDR systems and are benefiting from cost savings and increased efficiency. An analysis performed by the FDA indicated that companies can save almost 80 percent by submitting reports electronically rather than by paper. Leveraging existing complaint handling software capabilities will lead to additional incremental savings.
As the FDA worked to refine eMDR requirements, Sparta Systems, a leader in eMDR, worked collaboratively with the agency by performing extensive internal testing and providing feedback from first adopter customers. Our experience with eMDR throughout its regulatory evolution has given us the knowledge to be able to deliver the Sparta Systems eMDR Solution. Sparta Systems’ regulatory compliance software integrates complaint handling and eMDR reporting into the overall quality management system (QMS), allowing users to benefit from a single interface and eliminating the need for complex and costly custom integration.