Obelis Group – Your Consultant on EU Regulations
Obelis’ founder and CEO, Mr. Gideon Elkayam, created Obelis on September 27th, 1988 having a Vision in mind – “To Create Compliance for Safer Markets”. To achieve this, our Mission is ‘to be the consultant of choice by shaping the compliance industry and providing the most effective compliance process.’
In line with this vision, Obelis is committed to Horizon 2020, the EU Commission program for research and innovation – supporting various projects with novel technologies. As we believe that only a solid regulatory plan will bring great ideas from the design/lab to the market – Obelis supports several projects as their Regulatory Consultant.
Today, as one of the largest regulatory centers in Europe, ‘Employee satisfaction before client satisfaction’ serves as the driving force of our organization alongside other core values, such as: Entrepreneurship, Professionalism, Learning, Accountability, Diversity and Personal Integrity.
While retaining special expertise on Medical Devices, In-Vitro Diagnostics and Cosmetic Products, we do provide consultancy services for many different types of finished products, within the framework of the ‘NEW Approach’ Directives which may require the CE marking, an Authorized Representative and more.
These directives include, but are not limited to:
- Personal Protective Equipment
- Pressure equipment
- Radio and telecommunication equipment
- Electrical equipment
Located at a walking distance from the EEC Headquarters, Obelis aims to retain close contact with the EU administration. Towards that end, Obelis is an active member of a number of professional associations and EU commission working groups.
Some of our memberships include:
- Veteran member of the European Association of Authorized Representatives (E.A.A.R)
- Founding member of the European Responsible Person Association (E.R.P.A)
- Active member at the NB MED meetings for medical devices
- Active member of the EU Commission Medical Device Vigilance Committee
- Active member of the EU Commission IVD Technical Group
With a proven reputation in over 60 different countries around the globe, our vision is supported by a strong network of international representatives called the O.I.O. (Obelis International Offices).
If you would like to know more about Obelis, what we offer and how we can become your consultant of choice, please feel free to contact us.