The Medical Device Regulation is a Challenge.
Our goal is to help you meet the requirements of MDR
and understand and implement them.
You may find much information about the MDR requirements online but they are scattered and often do not fit together.
We therefore offer you our support in various forms.
We provide many of these completely free of charge:
My name is Sven Schaumann and I have been working as an engineer exclusively in the medical device industry since 2010.
Since then I worked numerous new developments, registrations and approvals of different medical devices.
After my studies I started into the medical device industry as a development engineer for hard- and software and hardware-related programming for several years.
My career then led me to various projects and different medical devices.
So I worked as developer, team leader, project manager but also QMB and risk manager in different projects and companies.
I was more and more involved with regulations and standards. This ultimately led me to several standards committees. And it led me to deal extensively with MDR – very practically oriented in several customer projects.
Implement immediately and close gaps
With the checklist package you gain more time and handle the most important topics faster by using: