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 ...
electronic
Medical Device Reporting Agent
for medical device manufacturers and importers
- One of your customer complaints or service reports represents a reportable event.
- Complete the MedWatch Form 3500A, in PDF version, just as you always have.
- Upload the MedWatch Form 3500 (PDF) to a file server that we set up for communicating with you.
- MedTech Review converts your file to the required XML format and submits to FDA's Electronic Submissions Gateway (ESG) on your behalf.
- Successful submissions result in three acknowledgements: arrival at FDA, arrival at CDRH, and upload to the MAUDE database.
- Copies of the submitted MedWatch Forms 3500A and all acknowledgements are provided as proof of on-time reporting.
Results Oriented
Submissions and Compliance
Contact us
612-889-5168