Your Trusted Partner for Global Regulatory Compliance
Your In-Country Representative of Choice For Medical Device Compliance in the EU, UK & CH
We support manufacturers of Medical Devices and IVDs with one-stop shop solutions for compliance
We register your products in EU, UK & Switzerland 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.
Get our free supporting tools
Download:
Subscribe & view to stay informed:
Obelis Group
Boulevard Brand Whitlock 30,
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
sales@obelis.net
© Obelis Group 2023
EU, UK, CH
"We feel very supported!"
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.
Javier Aravena
Regulatory Affairs Manager
"Their expert team helped us to avoid possible regulatory complications"
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.
Florian L. Gablenz
Business Development Manager
" Successfully launched our devices into multiple European countries"
I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.
Ran Amos
VP of Quality Assurance & Regulatory Affairs
Compliance Success stories
- 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
