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
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
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.