Why Obelis?
- Since 1988 – almost 30 Years of professional expertise (such as no other company in our domain!);
- Established in Belgium, Brussels – the heart of the European Union and regulatory affairs in Europe;
- The largest consultancy centre in Europe – with a team of over 60 consultants, ready to support manufacturer’s entry to the European Market;
- Solid international reputation – contributed to successful endeavors into the EU market of over 3,000 manufacturers from 66 different countries worldwide;
- Dedicated team of Experts ready to support you (Lawyers, Chemists, Pharmacists, Researcher, Scientists and others) - led by renowned experts such as Dr. Peter N. Ruys, John Webster, Jean-Marie Vlassembrouck, Louise Olliver and more.
- Qualified & knowledgeable personnel – trained bi-annually DIRECTLY by the European Authorities;
- Broad spectrum of services – European Authorized Representative, Responsible Person, Technical File Review/Creation, Product notification/national registration; Notified Body selection, Testing Guidance, Identification of Standards, Clinical Evidence, Risk management, Labeling Review, Vigilance, Free Sales Certificate, Training & Consultancy, Trade mark submission, On-site visits etc.
- Certified ISO 9001 & ISO 13485 – a solid indication of quality, consistency and continuous improvement;
- Active member of EU Associations and EU Commission Committees and Working Groups – providing our Clients with the most-up-to date news & developments;
- Chairman and Founder of E.A.A.R. (European Association of Authorized Representatives) – aimed to promote high standards of services and professional conduct among European Authorized Representatives.
- Well-known organizer of international Seminars & Workshops in cooperation with Authorities worldwide – a unique position of Obelis as a medical device industry lecturer!
- Strong network able to provide Obelis Clients with local regulatory solutions in 20+ markets worldwide such as: Australia, Brazil, China, Egypt, India, Israel, Japan, Korea, Malaysia, Philippines, UAE, Indonesia, Vietnam, and many more.
- Strong international presence – with offices in Brussels, USA, Israel, China and international representation in over 15 countries and participating in over 20 exhibitions every year!
