Towards international markets
Thanks to our network of partner Agencies in more than 20 extra-European Countries, we carry out preparation and support activities for the registration of medical devices and in vitro diagnostic medical devices at the foreign Regulatory Activities.
- Feasibility analysis for placing on the market in the target country.
- Identification of pre- and post-market regulatory requirements.
- Pre-screening of the documentation for the adaptation to international regulation.
- Dossier preparation/registration practices (510(k), MDAL, STED, ASEAN CSDT, dossier, ecc…).
- Post-practical submission monitoring.
- Licence holding e Local Representative service.
- Support in the management of correspondence between the company and the Regulatory Authority of the reference country.
- Regular renewals.