GLOBAL SALES CERTIFICATIONS
WE TAKE CARE OF THE SALES CERTIFICATION PROCESSES FOR THE GLOBAL MARKETS
(US, EU, ASIA)
We have registered hundreds of healthcare devices around the world. The most common registrations are to Europe (CE) and the US (FDA, 510(k), PMA, De Novo).
We register medical devices in all risk classes (I, IIa, IIb, III)
THE SALES CERTIFICATION PROCESS CONTAINS
- creation of a global regulatory plan
- definition of the medical purpose of use for the target market
- realization of the application process
- recruitment of necessary local contacts together with the client
- realization of the registration
