United States Services

Advena Ltd.’s office in the United States can assist your company by providing the

following services:

- FDA US Agent / Official Correspondent services

- Establishment registration and renewal

- Device listing

- 510(k) Submissions

- PMA Submissions

- Quality System development

- FDA inspection and response

- cGMP Training

Why choose Advena Ltd. to assist you in preparing your medical device for marketing in the

United States?

- Personal service

- Competitive rates

- Flexible terms

- 9 years experience

- Dedication to your success

- Support for both EU and US regulations

- Certified by US Chamber of Commerce and SBA in Import/Export regulations