1med Sa

1MED is a full-service CRO and regulatory consultancy specialising in MedTech, biotech and pharmaceutical development. We provide end-to-end support including ISO 13485-compliant quality management, MDR/IVDR regulatory strategy, and clinical trials from first-in-human to post-market studies. Founded in 2014 and headquartered in Agno, Switzerland, 1MED employs 100+ professionals delivering global operational support. Our mission is to help MedTech innovators navigate the complexity of developing safe, effective medical devices in compliance with MDR and FDA regulations. Our expertise spans the entire product lifecycle—from research and preclinical testing to quality system implementation, regulatory submissions, clinical study management and post-market activities. This cross-functional approach has contributed to the certification or maintenance of more than 500 medical devices in recent years. We support clients ranging from start-ups to global leaders, across therapeutic areas including cardiovascular, orthopedic, ophthalmology, dental, dermatology, wound care, gastrointestinal, urology, surgical tools, drug delivery systems, IVDs and software/AI-based devices. In addition to in-house capabilities, 1MED maintains strong partnerships with preferred vendors, European Notified Bodies and Competent Authorities. Learn more at or contact info@1med.ch