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.
Request a quote for CH-REP
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.
Request a quote 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.
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.
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software and what rules apply in the development.»
«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.»
