We simplify market access for medical devices

We go beyond consulting as a legal manufacturer. Our proven experts guide you through the CE certification. You gain legal protection, reduced risks and faster time-to-market.

Benefit from a simpler way to your CE mark

Minimize liabilities and risks

Safeguarded by Decomplix, you minimize product liabilities and overall risks. We ensure you stay within your budget.

Obtain CE with proven experts

Decomplix becomes your professional compliance staff, guides you to your CE and is responsible for your compliant quality management.

Enter the market faster

You can start immediately with the product’s CE certification. With Decomplix, staff recruiting, Notified Body hiring and ISO 13485 certification are already completed.

Market expansion with hands-on support

We have the know-how to enter new markets and sustain your compliance during sale.

I am interested in a customized
plan for my CE marking.

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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 have that covered. With us at your side, you already fulfill those requirements and can focus directly on getting your product CE marked. Once your product is on the market, we ensure CE maintenance and post-market surveillance.

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.

Simon Ackermann

Simon Ackermann VostraMed AG

«With calculable costs for quality management and regulatory affairs, we have flexible access to excellent and varied know-how.»

Matías Hosiasson

Matías Hosiasson Biomedical Devices SpA

«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»

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