Advanxa
EU Market Access – Auth. Rep. and Consulting services
We guide companies that seek to enter the EU market by providing Auth. Rep. and compliance support
With our SMEs team we provide support to worldwide organization aiming to commercialize products in the EU.
We can help to get your medical device product ready for CE mark and registered in the EU.
We review your product documentation and testing data to assess compliance to applicable standards for your products.
We find best solution for your current status and plans in order to allow you to be ready to register your products in the EU.
Full package service including: documentation drafting, notified body liaison, certification, EU Auth. Rep. support.
We remain available during the whole CE Marking process and after it to make sure you are up to date and in compliance.