confinis

confinis is a global consulting firm based in Switzerland, specializing in regulatory affairs and quality management for medical devices, combination products, and in-vitro diagnostics. Established in 2005, the company operates from offices in Switzerland, the USA, and the UK, serving clients around the world. The firm offers a wide range of services, including regulatory affairs, quality management, design control, risk management, clinical evaluation, and post-market surveillance. They also provide US agent services for companies without a US presence, helping them navigate FDA requirements. Their diverse clientele includes corporate clients, small and mid-sized enterprises, educational institutions, and research facilities, all benefiting from tailored solutions that ensure compliance and efficiency. The multidisciplinary team at confinis consists of engineers, scientists, and medical doctors, combining theoretical knowledge with practical experience. Their business philosophy emphasizes filling gaps in regulatory and quality management needs, positioning confinis as a trusted partner in the medical technology sector. They also offer an FDA Expert Matchmaking service to connect manufacturers with FDA experts, streamlining regulatory submissions and approvals.

• Employees 25
• Founded 2005