We simplify market access for medical devices.

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.

Our goal is to simplify and speed up the CE certification of your medical product.

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

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 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.

ISS AG, Integrated Scientific Services’ staff ensures capacities, considerable knowledge and experience in the areas of medical device software development, quality management, clinical and regulatory affairs.

CE plus GmbH is a Germany-based regulatory affairs service provider for medical devices and in-vitro diagnostics. CEplus supports with regulatory expertise in development and speeds up the market access for our customers.

sitem-insel AG aims to facilitate the application of research results in medicine (translation). It provides researchers with training, consulting and infrastructure and offers Decomplix access to important clinical areas.

As a cloud pioneer, netrics AG provides secure IT services from its own Swiss-based data centers in combination with cloud offers, particularly for highly regulated markets like health care and the medical device industry.

Beutler Künzi Stutz AG is our specialist for legal affairs. Our customers benefit from their knowledge and experience in data protection, intellectual property and information technology matters.

Creaholic is an innovation factory focused on inventing and innovation culture. Having these makers, doers, and prototypers aboard help circumvent the pitfalls of launching a new product or business.

Optimo Medical AG is a related start-up providing software as a medical device for surgeons. We collaborate with Optimo to share know-how and gain better understanding of start-up needs.

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


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 for Decomplix?

Looking for a new challenge? Are you inspired by the idea of accelerating innovation in the medical industry? Do you thrive on diversity?

Send us a message