Your Trusted Partner for Global Regulatory Compliance

Your In-Country Representative For Medical Device Compliance in the EU, UK, CH & US

We support manufacturers of Medical Devices and IVDs with one-stop shop solutions for compliance

We register your products in EU, UK, Switzerland and US in 3 working days!

Why Obelis?

Experience

Founded in 1988, we are among Europe’s largest centres for advisory and representative services.

ISO Certification

We are certified by ISO 9001:2015 and ISO 13485:2016.

Commitment to Compliance

We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.

Proximity to EU Institutions

We are members of professional associations and more than 10 European Commission working groups.

International Network

Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.

Our Team

Our team consists of lawyers, chemists, pharmacists, and other experts.

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Obelis Group

Boulevard Brand Whitlock 30,

Brussels, 1200, Belgium

Tel: +32 (0)2 732 59 54

sales@obelis.net

Territories

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Industries

Information platforms

Mdlaw.eu

Coslaw.eu

Prodlaw.eu

EU, UK, CH, US

About Us

Authorised Representation (EC REP)/ Responsible Person (UK RP)
EUDAMED device and actor registration
Device registrations to the EU & UK authorities (MHRA)
MedDO/ IvDO & MDR/ IVDR technical documentation review
Assist with CE & UKCA marking
Vigilance and incidence reporting
MDlaw.eu news, alerts, templates and guidelines
Compliance trainings

Client Success stories

I encourage companies to seek compliance before putting their products on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.

We successfully launched our products into multiple European countries.

Ran Amos

VP of Quality Assurance & Regulatory Affairs

We were under huge time and cost pressure for a new OEM product line launch and we relied on Obelis. It was the right decision, their expert team helped us to avoid possible regulatory complications.

Their expert team helped us to avoid possible regulatory complications

Florian L. Gablenz

Business Development Manager

We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make it seem so easy.

We feel very supported!

Javier Aravena

Regulatory Affairs Manager