If you also want to market your product internationally, you can concentrate fully on the development of your medical product, we take care of the approval.
In the first step, we plan the international approval for you and determine which classification your product falls under, whether clinical studies are necessary, establish contact with the foreign authorities, clarify the respective approval process for you and check which documents are required for approval .
After the formalities have been checked, we will accompany you in all preparations for approval by creating the country-specific technical documentation (STED) for you, checking existing STEDs and adding or improving them if necessary.
And we won’t leave you alone with the actual approval by the respective local authorities.
Contact EU Representative
Contact us to find out more about the MEDAGENT service and the EU representative.