Debiotech SA Information

Debiotech is your strategic partner in the development of medical devices. As a service provider, we chose over 30 years ago to focus exclusively on innovation in medical technology. We help you bridge the gap between idea and technological implementation. Our multi-disciplinary team of experts is fully dedicated to solving your problems (no in-house product design or sales; you own the intellectual property). We specialize in the design of complex medical devices for regulated markets. We know that the needs, requirements, and regulatory constraints of the Medtech sector evolve rapidly. That's why we follow an agile methodology that enables us to deliver tailor-made solutions in record time, while maintaining a high level of quality and safety. ISO 13485 certified, QMS following FDA 21 CFR Part 820 and MDR requirements as well as ISO/IEC62304, 60601-1, 62366,14971, … to create for you a safe and reliable medical device. SERVICES: At you side at any stage of your project, Ideation, Proof of Concept, MVP, entire MD development Innovation management, specifications writing, risk management, feasibility studies. Documentation under Design Control Mechanical, electronics and software engineering Integration and management of complexity thanks to systems engineering Testing and quality engineering Cost optimization