Electronic Medical Device Reporting (eMDR)

eMDR Management for Medical Device Companies

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.
Sparta worked collaboratively with the FDA while the agency developed eMDR requirements.  Our experience with eMDR throughout its regulatory evolution has given us the knowledge to be able to offer an eMDR solution.  The solution also links complaint handling to eMDR  allowing users to benefit from a single interface, and eliminating the need for complex and costly custom integration.

Benefits of Sparta's eMDR and Complaint Handling Solution

  • Reduces the costs associated with paper, shipping, resources, repetitive data entry, and errors due to manual process.
  • Links complaint handling, adverse event reporting, and eMDR reporting with FDA regulations to provide visibility from initial complaint to vigilance report.
  • 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.  
  • Supports dozens or even thousands of submissions per month.
  • Consolidates and improves regulatory assessments and medical device reporting with integrated decision trees and direct regulatory report generation.

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