eMDR: Electronic Medical Device Reporting
Medical device companies are required to report certain adverse events electronically to FDA. This process, known as eMDR (Electronic Medical Device Reporting), is mandatory for manufacturers, importers, and device user facilities.
USAgentPros helps device companies set up, manage, and submit eMDR filings quickly and accurately.
Who Must Submit eMDR Reports?
- Medical device manufacturers
- Initial importers of devices
- Device user facilities (e.g., hospitals, clinics)
Reports must be submitted when a device may have caused or contributed to a death, serious injury, or malfunction.
Our eMDR Services
- FDA eMDR system setup and configuration
- Preparation and electronic submission of reports
- Ongoing support for follow-up or supplemental reports
- Recordkeeping and compliance monitoring
Why It Matters
Failing to file eMDR reports correctly can lead to:
- FDA enforcement actions and fines
- Increased regulatory scrutiny
- Delays in keeping devices on the U.S. market
Why Device Companies Trust USAgentPros
Dedicated Compliance Pro – Guidance through every eMDR requirement
Fast Turnarounds – Timely reports that meet FDA standards
100% Money-Back Guarantee – Confidence in every submission
Competitive Pricing – Reliable compliance support at a fair cost
Stay Compliant with eMDR Requirements
Ensure your medical devices remain in the U.S. market without interruption. Partner with USAgentPros for accurate, on-time eMDR submissions.