Founder, Owner, CEO
Our story began in 1988, when our CEO, Mr Gideon Elkayam, founded Obelis driven by the vision to create compliance for safer markets. Over the years, this unique vision has helped us build a remarkable standing in our field of specialization by turning us into the most significant center for regulatory services in Europe. And being based in Brussels, at the European Union’s center, has allowed us able to collaborate with the EU institutions regularly and swiftly.
Today, we can say that we have played our role in shaping the compliance industry European Union, Switzerland and United Kingdom. But our journey did not lead us astray from our original goal: every day, we continue to support our worldwide clients in navigating the regulatory maze. In three decades, we have worked with more than 3.000 manufacturers from over 60 countries.
But what is it that makes us so special? The fact that we see ourselves not only as your Consultant of choice but also, and firstly, as a partner whose purpose is to help your business grow.
Obelis Group stays by your side on your journey into and across Europe.
Our Values
On a regulatory level, Obelis is committed to compliance and product safety in Europe.
But we also treat our values seriously within our own ranks. Thus, we provide both our clients and ourselves with a competitive edge. In other words, we care for our clients, our people and our future.
Team
Meet the dynamic team creating compliance for safer European markets. The Obelis team is led by a Board of Directors that brings decades of professional expertise in Regulatory Affairs and Quality Assurance within the European Union. To help us work towards the mission “To be the consultant of choice by shaping the compliance industry and providing the most effective compliance process”, we’re supported by an Advisory Board.
This is comprised of several accomplished experts with extensive experience in Regulatory Affairs, medical technology, lobbying, business management, marketing and organizational development.
Last but not least, we have our team of Managers & expert consultants facilitating compliance and entry onto the European market for manufacturers in multiple sectors from medical devices and cosmetics to consumer goods.
Board
Managers
Mathias Acciai
Customer Relations
Siana Slavova
Marketing
Ajda Mihelčič
Publications
Roland Gerard
Quality Management
Luminita Pascanu
Quality Management
Davide Turchi
Regulatory Affairs
Floriana Dibitetto
Research and development
Shikha Malhotra
Sales
Martina Quitadamo
VIP department
C level
Audrey-Flore Ngomsik
Chair of the Business Operations Working Committee
Dirk Pekelharing
Chair of the Regulatory Affairs Working Committee
Emile Peters
Chair of the Information and Technology Working Committee
John L. Webster
Chair of the Implementation Working Committee
Pierre de Potter
Chair of the Human Resources Sub-committee
Jean-Marie Vlassembrouck
Chair of the Information and Technology Working Committee
Partners
While Obelis core services are exclusively focused on the EU Market allowing us to maintain a high-level of services and expertise towards the EU Market, our clients have the additional benefit of gaining access to our world-renown Obelis International Offices (OIO) Network.
Obelis International Offices are independent partners who are able to provide our clients with solutions offering the same level of expertise and professionalism in other global markets of their choosing. Each partner will be able to provide an independent quotation of their service relevant to the local requirements. Obelis International Offices (OIOs) are located around the world, in 11 different countries. This provides a powerful international network. If you’re having trouble understanding or meeting EU regulations for selling your products in Europe, there is a representative near you who can explain and advise what you need to do in your language.
A dedicated European Authorised Representative is required for any non-European manufacturer who wants to sell their medical devices in the EU. Through our network of OIOs, we can provide you with:
- High-quality, personal services tailored to your specific compliance needs
- Easy access to regulatory solutions and support from within the market
- The same commitment to quality, standards and values that you’d receive from our headquarters in Brussels
- Dedicated training and ongoing support from our expert team of regulatory consultants
Become a partner
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
About us
