Serving both the In Vitro Diagnostic and Medical Device industries, MDSS specializes in European regulatory affairs. MDSS acts on behalf of its clients as “Authorized Representative” according to the "NEW" European CE regulations - IVDR 2017/746. Certified to EN ISO 13485, we consult on quality-/risk management systems and all related services to achieve CE-approval. MDSS provides customized services for product registration, incident reporting, recall management, labelling, technical files...