UNITED STATES AGENT SERVICES FOR MEDICAL DEVICES

U.S. Agent for Medical Devices Basic Services:

• Responding to questions concerning the registrant's products that are imported or offered for import into the United States
• Assisting FDA in communications with the registrant
• Maintaining Secure Records as required by FDA regulations
• Assisting FDA in scheduling inspections of the registrant's foreign establishment
• Providing Hand delivery document submissions to the FDA/CBER offices for faster service.

New Registrants retain AGDE Corporation as your U.S. FDA AGENT for Medical Devices

• Click here to contact AGDE Corp and receive your U.S Agent for Medical Devices Agreement and payment instructions

To Extend your current U.S. Agent Agreement Click on the Order Now button

 Learn More about Medical Device Registration...

Consulting Services

AGDE Corporations additional fee services for:

• Establishment Registration and Listing
• Mock Inspections of your Facilities
• Quality System (QS) Compliance Review
• CGMP Review
• Small Business Qualification Certification Review
• GAP Analysis per ISO 9001/ISO 13485 Standards

   Click here to learn more and contact us for a quote