Electronic Medical Device Report (eMDR)


Submit MedWatch form electronically through ETQ's eMDR tool.

eMDR Electronic Medical Device Report

Working with representatives from the Food and Drug Administration (FDA), ETQ has developed a tool that will allow users to submit Electronic Medical Device Reports (eMDRs) to the FDA gateway, seamlessly and efficiently. This tool for ETQ Reliance, enables Medical Device manufacturers to electronically automate the quality process for medical device, while complying with quality and FDA compliance standards. Using ETQ's eMDR, not only are users able to automatically submit their reports directly to the FDA, but they are also provided with a level of functionality that ensures fewer submission errors, tying the submission process directly into the Complaint Handling Software and Corrective and Preventive Action (CAPA) Software workflows.

Benefits of Implementing ETQ's eMDR Regulatory Submission Tool

  • Robust system integrates with the FDA
  • Speeds communication with FDA and allows two-way communication
  • Fosters real-time collaboration with the FDA
  • Immediate receipt of submission
  • Ability to easily flag submissions
  • Reports can be sent out in batch and scheduled for submission as opposed to sending out single reports sporadically
  • Serves as central location for all information
  • All receipt acknowledgements from the FDA are lined up automatically with the corresponding submission
  • Incorporates QMS functions - Complaint Handling Software, CAPA Software, Risk Assessment, and more
  • Follows the HL7 ICSR standard for reporting adverse events in medical device
  • Allows you to integrate ETQ's Complaint Handling forms directly to the FDA eMDR Regulatory Submission tool, seamlessly

eMDR will soon be required. Check out all the tools you need for compliance.

Download Now

In the past, an eMDR form was completed manually and then mailed or faxed to the FDA, resulting in an overall process that took days or more. ETQ eMDR enables organizations to seamlessly submit reports to the FDA, eliminating the need for manual processes and increasing efficiency in the overall process. Using eMDR, acknowledgment of submission is made within 6-12 minutes of receipt.