MDC Regaffairs

MDC Regaffairs is a specialized consultancy firm providing regulatory affairs and quality management services to the medical device and in vitro diagnostic (IVD) industries. Based in Germany, the company assists manufacturers in navigating complex European and international regulatory frameworks, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Their service portfolio includes the preparation of technical documentation, clinical evaluation reports, and the implementation of ISO 13485-compliant quality management systems. Additionally, they offer strategic advice for market access and act as a bridge between manufacturers and notified bodies. The firm is recognized for its expertise in ensuring compliance for high-risk medical products entering the European market.