inmedis is your Swiss partner for Regulatory Affairs and Quality Management in medical technology. We support manufacturers, suppliers and importers in a practical manner in the development, authorization and market launch of medical devices. Our expertise includes: setup and auditing of QMS (ISO 13485, ISO 9001, FDA QSR, MDSAP), Regulatory Affairs (approval strategies, MDR/IVDR, PMS, vigilance), technical documentation, validation (processes, design, CSV), biocompatibility (ISO 10993) as well as interim management and due diligence. With many years of experience we create compliant, efficient solutions – from strategy to operational implementation - since 2007.