Obelis Group S.A.

Founded in 1988, Obelis is one of Europe's leading regulatory compliance partners, helping more than 7,000 manufacturers from over 90 countries bring medical devices and IVDs to international markets. With more than 38 years of experience, we support manufacturers throughout the entire product lifecycle, from regulatory strategy and technical documentation reviews to registrations, market access and post-market compliance. Our multidisciplinary team of regulatory experts is committed to making compliance simpler, faster and more efficient.

Operating across the European Union, United Kingdom, Switzerland, United States, Canada and Türkiye, Obelis provides a comprehensive range of services, including EU Authorised Representative (EC REP), UK Responsible Person, Swiss Authorised Representative, US Agent and Official Correspondent, as well as EUDAMED, MHRA, FDA and Health Canada registrations, Quality Management System (QMS) support and ISO 13485 guidance. Backed by ISO 9001 and ISO 13485 certifications and an active role in shaping regulatory developments, we help manufacturers confidently navigate evolving regulations and accelerate global market access.