eMDR Solution

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.

eMDR: Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting

Benefits of Customer Complaint Handling and eMDR Solutions:

  • Reduces the costs associated with paper, shipping, resources, repetitive data entry and errors due to manual process
  • Integrates complaint handling, adverse event reporting, and eMDR reporting in accordance with FDA regulations to provide clear traceability from initial complaint to ultimate vigilance reports around the world
  • Addresses the full range of specific FDA eMDR requirements including acknowledgement processing and proper handling of error conditions to ensure compliance and reduce risk
  • Accommodates built-in controls to monitor status of adverse events and escalate those that are about to become overdue
  • Satisfies eMDR reporting requirements as one key element within a global regulatory reporting strategy.  A uniform “look and feel” and consistent usability across all appropriate reporting jurisdictions provides a coherent user experience.
  • Adds efficiency and accuracy to organizations with as few as 10 reports in a month, while delivering proven scalability to support thousands of submissions per month
  • Consolidates and improves regulatory assessments and medical device reporting with integrated decision trees and direct regulatory report generationClick here to learn more about Sparta Systems eMDR Solution TrackWise

Click here to learn more about Sparta Systems eMDR Cloud Solution 123Compliance

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