Minimize liabilities and risks
Safeguarded by Decomplix, you minimize product liabilities and overall risks. We ensure you stay within your budget.
Benefit from a simpler way to your CE mark
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.
Enter the market faster
You can start immediately with your medical 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 medical compliance during sale.
Interested in a customized
plan for CE marking?
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.
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 VostraMed AG
«With calculable costs for quality management and regulatory affairs, we have flexible access to excellent and varied know-how.»
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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How medical device distributors remain compliant under the EU MDR
23.03.2020
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Guidance on medical device significant changes
04.02.2020
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