In order to sell medical products, lab equipment and IVD products in another country, it is necessary to register the product with EUDAMED and aquire the CE certificate according to EU-MDR or EU-IVDR.

To obtain these we advise to perform a gap analysis first. We also support you with the function of PRRC, person responsible for regulatory compliance. Our regulatory strategy consulting will guide you and provide orientation on all topics related to market authorization.