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Medical Devices and In-Vitro Diagnostics

Helping navigate fast-changing regulatory landscapes, Obelis guides manufacturers through the European, British, Swiss and American legislation.

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  • 35+ years of experience
  • 7000 + clients worldwide
About the industry

Launching your medical devices in profitable world markets

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Road Map
1. Collection of documentation
2. Mandate issuance
3. Noticifation (if applicable)
4. Successful access to the EU market

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

  • Europe’s leading center for regulatory consultancy and representative services
  • ISO 9001:2015 and ISO 13485:2016 certified
  • Since 1988, we supported 3,000+ manufacturers from 60+ countries
  • Members of professional associations and European Commission working groups
About us
European Union
Switzerland
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What clients are saying

“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”

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Ran Amos VP of Quality Assurance & Regulatory Affairs at Samsara Vision

“Obelis helped us navigate complex regulatory landscapes, ensuring we met all legal and industry-specific obligations. Obelis deeply understands the cosmetic regulatory landscape and they have provided all the necessary support”

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Terry Luu Chemist at Home and Body Co.

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

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Mr. Florian L. Gablenez Business Development Manager at Dirk Rossmann GMBH

Start your compliance journey with Obelis.