MedTech Review has taken all of the thought, planning, design, and testing required to implement eMDR software and systems on your behalf.  Our eMDR Agent service is designed for small to medium enterprises who normally file few, if any, device events, and who don't want to spend the resources to set up and manage the electronic system in accordance with strict FDA rules and standards.


Our service provides you with the system that avoids a 483 for no electronic means to file under 21 CFR 803.


How the service works ...



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Contact us

Global Medical Device Consultants

electronic

Medical Device Reporting Agent 

for medical device manufacturers and importers

Submissions and Compliance


Results Oriented 
  1. One of your customer complaints or service reports represents a reportable event.
  2. Complete the MedWatch Form 3500A using FDA's eSubmitter software
  3. Package your submission and email the *.zip file to us
  4. MedTech Review reviews your file and submits to FDA's Electronic Submissions Gateway (ESG) on your behalf.
  5. Successful submissions result in three acknowledgements:  arrival at FDA, arrival at CDRH, and upload to the MAUDE database.
  6. ​Copies of the submitted MedWatch Forms 3500A and all acknowledgements are provided as proof of on-time reporting.