Minimize liabilities and risks
Safeguarded by Decomplix, you minimize product liabilities and overall risks. We ensure you stay within your budget.
Safeguarded by Decomplix, you minimize product liabilities and overall risks. We ensure you stay within your budget.
Decomplix becomes your professional compliance staff, guides you to your medical CE mark and is responsible for your compliant quality management.
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.
We have the know-how to enter new markets and sustain your medical compliance during sale.
Interested in a customized
plan for CE marking?
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.
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«With calculable costs for quality management and regulatory affairs, we have flexible access to excellent and varied know-how.»
«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»
«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»