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.
Swiss Authorised 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.
Sang-Il Kim Federal Office of Public Health FOPH
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
Pascal Reichmuth Rikai AG
«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.»
Simon Ackermann VostraMed AG
«With calculable costs for quality management and regulatory affairs, we have flexible access to excellent and varied know-how.»
Markus Piller Medid AG
«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.»
Matías Hosiasson Biomedical Devices SpA
«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»
José Näf nahtlos GmbH
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
Latest from our blog
30.07.2021
Job Postings
Junior Regulatory Affairs in Medtech (50% or more) (F/M)
25.07.2021
Knowledge
UDI for Medical Device Software (MDSW) under EU MDR
23.07.2021
Knowledge
