We simplify market access for medical devices

Our proven experts guide you through the CE certification. You gain hands-on support in regulatory affairs and quality management, ensuring your compliance. Plus, as a Swiss Authorised Representative, we facilitate your market access in Switzerland.

Benefit from our compliance services

Swiss Authorised Representative

As your Swiss Authorised Representative (CH-REP), we ensure your market access in Switzerland. Our high level of compliance and regulatory knowledge was confirmed with a Swissmedic inspection with no non-conformities in April 2022.

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Obtain CE mark with proven experts

Decomplix becomes your professional compliance staff, guides you to your medical CE mark and is responsible for your compliant quality management. You get expert opinion on the major regulatory roadblocks in the path to market for your product.

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Skip steps to your CE mark and save time

Don’t worry about finding reliable CE compliance experts, working with a Notified Body or getting your company ISO 13485 certified – we will cover that for you. With us at your side, you already fulfill those requirements and can focus directly on getting your medical product CE marked. Once your product is on the market, we ensure CE maintenance and post-market surveillance.

Swiss Authorized Representative

Keep market access in Switzerland
for your medical device

We work with medical device and in-vitro diagnostic companies of all shapes and sizes, from startups to corporates, from Switzerland to all around the globe.

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