Technical Documentation Review

MDR/IVDR Consultancy (CE, UKCA, MedDo)

Authorized Representative (EU, UK, SWISS)

Medical Device Registration (EUDAMED, MHRA, MedDo)

Why you should choose Obelis?

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Our Services:

We represent the largest center for consultancy in Europe

Creating compliance for safer markets is in our roots.

At Obelis, we registered over 15,000 cosmetic products in Europe, helping more than 3,000 companies over 70 countries to sell their products on the European market.

We have more than 30 years of business experience

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups.

We are ISO 9001:2015 & 13485 Certified

Ensuring the highest quality of service for your business in Europe.

Co-founders of the European Responsible Person Association (ERPA) & European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets accross the world.

YOUR REPRESENTATIVE IN THE EU, UK & SWISS MARKETS

Obelis Group is a quality driven, service oriented company with over 30 years of experience in regulatory affairs.

In supporting brand owners in gaining EU Compliance, we act as professional European Authorized Representative & EU Responsible Person.

As your EU, UK & CH Consultant, Obelis supports your product launch to the European market.

We are the largest center in Europe for CE Marking & European Representative Services

We register your Medical Devices and IVDs in Europe in 6 working days!