Med-Di-Dia

Med-Di-Dia is a regulatory and quality compliance consultancy based in Galway, Ireland. It supports medical device, IVD and digital health companies with EU MDR and IVDR market access, CE marking, EU Authorised Representative and PRRC services, technical files and clinical evaluations. For the United States, the firm advises on device classification and FDA 510(k), PMA and De Novo submission routes.