REGULATORY AUTHORIZATIONS

IRI-CE supports you in obtaining your regulatory authorisations, in particular by providing services such as:
- Process of obtaining CE marking
- Process of obtaining international regulatory registrations (UK, Switzerland, US, Brazil, Canada, Australia, Japan, Korea, India....)
- Procedures with the European Commission Eudamed (SRN and registration of establishment, registration of DMS and their UDI, communication PSUR, MIR, FSN, FSCA)
- Elaboration of the technical documentation according to the model of the ON
- Management of promotional materials
- Management of portfolios of regulatory authorisations for the marketing of MDs