US FDA Agent
Qserve's US FDA Service Package
Assist FDA in communication with the foreign manufacturer
Initial registration of the new establishment
Annual update of registration and device listing records
Assist FDA in scheduling inspections of the foreign establishment
Initial listing of medical devices that will be imported
Two hours of regulatory support/advice
Qserve template to facilitate importation
Not included in the service package:
Adverse event/MD reporting
GUDID/UDI registration
As a full-service consultancy, Qserve can provide solutions for these services under a separate contract.