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Worldwide Compliance for Medical Devices

Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Switzerland, and beyond to support your compliance needs effectively.

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Select your region

Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

European Union

The European Union medical device market, serving over 500 million patients, offers vast opportunities but requires strict compliance with Regulation (EU) 2017/745 (MDR).

United Kingdom

The United Kingdom’s medical device market remains a key opportunity post-Brexit, but requires navigating its own regulatory framework, including UK-specific compliance for market access.

United States

The United States is the world’s largest and most lucrative medical device market, offering vast opportunities but demanding rigorous FDA compliance for market entry.

Switzerland

Switzerland’s medical device market is innovation-driven and closely aligned with EU standards, but requires non-Swiss manufacturers to meet national obligations.

Canada

Coming soon…

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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.

About us

Experience

Founded in 1988, we are among Europe’s largest centres for advisory and representative services. We are proud to have helped over 7,000 manufacturers from over 90 countries address their regulatory challenges.

ISO certification

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

Proximity to global institutions

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

Diverse experts

Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.
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Start your compliance journey with Obelis.

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