inmedis is your Swiss partner for quality management and regulatory affairs in the medical device industry. Our experienced experts support you pragmatically and goal oriented in the following areas: - Quality management systems: ISO 9001 / ISO 13485 / FDA QSR / Audits / MDSAP - Interim Quality Management Resources: Outsourcing of QM/RA functions / coaching and support - Technical Documentation: MDR-compliant technical documentation / gap analyzes / reviews - Validation: Design and manufacturing processes / Computer systems (CSV) - Biocompatibility: Planning and implementation / ISO 10993 - Regulatory affairs: Approval strategy and registrations / Post-market surveillance and standards monitoring