Regulatory strategy for CE marking and gap analyses.
Get a solid starting position that saves you time in your project and supports you heading in the right direction.
We take care of the CE certification
of your medical device.
Our proven experts guide you through the CE certification of your
medical device.
Start by finding out what you need for the CE marking of your medical device. Decomplix offers an expert assessment of your situation with interactive workshops and flat-rate pricing. Then choose the hands-on support that serves you best. We tailor our team to your individual needs. If you think we could support you in any way, let’s talk!
Get a solid starting position that saves you time in your project and supports you heading in the right direction.
Make your technical documentation compliant with tailored gap analyses, rapid feedback and compilation support.
Gain clarity with expert opinions on your compliance questions and assumptions to prevent misinterpretation.
100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Decomplix provides all you need for your CE compliance from one source.
Decomplix operates under a ISO 13485 certified quality management system.
Decomplix’ customers benefit from easy- to-use digital tools with secure and compliant IT infrastructure.
Decomplix stands by as a coach in CE compliance matters and as the customer’s close contact to Swiss authorities and EU notified bodies.