Regulatory Affairs Team

The Regulatory Affairs Team at 1MED SA is responsible for ensuring that medical devices, novel technologies, and combination products developed by the company and its clients meet all regulatory requirements. This includes providing strategic regulatory advice, preparing and submitting documentation for certifications, managing communications with European Notified Bodies and Competent Authorities, and ensuring ongoing compliance with the Medical Device Regulation (MDR). The team plays a critical role in facilitating the successful market entry and maintenance of innovative medical products.