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