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The Medical Device Regulation is a ​Challenge.

​​Our goal is to help you meet the requirements of MDR
​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:

  • Expert Blog
  • ​Newsletter for experts in ​medical device industry
  • ​​​​Templates
  • ​​Online courses and webinars

About the author

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.

Sven Schaumann

Engineer for electrical and
information technology

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