United States Services Advena Ltd.’s office in the United States can assist your company with registration and representation of your medical devices in the United States by providing the following services • FDA US Agent / Official Correspondent services • Establishment registration and renewal • Device listing- 510(k) Submissions • Quality System development/audits • FDA inspection and response • cGMP Training • Document Control systems • Monthly regulatory updates Why choose Advena Ltd. to assist you in preparing your medical device for marketing in the United States? • Personal service • Competitive rates • Flexible terms • 10 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