In contrast to a consultant, we can assume the pre- and post-market responsibility as the legal manufacturer. We provide compliance staff, a Notified Body and ISO 13485 certification to the partnership. To stay on the market, we maintain the CE certificate and stand by your side.Discover our services
We simplify market access for medical devices.
Our goal is to simplify and speed up product certification services. It can be complicated, expensive and time-consuming to certify medical devices on your own. Our solution solves this problem by providing you with compliance staff so that your company and product meet the increasing regulatory demands fast and hassle-free. Each customer is unique, so Decomplix adjusts the service and pricing to their real needs. Whether it’s a certification experience from one source or simply guidance on the regulatory pathway, we are constantly challenging the definition of what it means to be a compliance partner – with the shared vision of accelerating innovation and encouraging the breakthrough of great ideas.
We go beyond consulting as a legal manufacturer
We can provide all you need for your compliance from one source.
Decomplix is based on the profound expertise of our best-in-class partners. Through this responsible network, we can also provide additional services and pricing approaches.
Our proven experts guide you through the CE certification
Markus Angst Senior Regulatory & Quality Consultant Decomplix AG
Beni Hirt Customer Relations & CEO Decomplix AG
Helena Lacalle Senior Regulatory Affairs Manager Decomplix AG
Anna Mårtensson Senior Project Manager Decomplix AG
Robert Matovinovic Senior Quality Manager Decomplix AG
Josef Neubauer Quality & Account Manager Austria Decomplix AG
Sandra Item Head of Regulatory Affairs & Knowledge Management ISS AG, Integrated Scientific Services
Hans-Martin Oetiker Chief Compliance Officer, Cloud & Cyber Security netrics AG
Hansjörg Riedwyl Business & Regulatory Strategies, CEO ISS AG, Integrated Scientific Services
Matthias Steck Senior Software Engineer ISS AG, Integrated Scientific Services
Michel Weber PhD Head of Clinical Services ISS AG, Integrated Scientific Services
Want to work with Decomplix?
Do you know someone looking for a challenging experience? Are you inspired by the idea of accelerating innovation and encouraging the breakthrough of great ideas as a first-mover on the market? Do you thrive on diversity?Let's talk