​​Get the overview


​​​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:


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

Dipl.-Ing.

Sven Schaumann

​Engineer for electrical and information technology

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.

​MDR Checklist Package

​​Implement immediately and close gaps
With the checklist package you gain more time and ​

handle the most important topics faster by using:


  • ​Checklist "GSPR" ​according to MDR ​Annex I
  • ​Checklist "GSPR" ​according to IVDR ​AnnexI
  • ​Checklist MDR STED-Format ​​for your technical documentation ​according to Annex II
  • ​​Checklist ​​IVDR STED-Format for your technical documentation according to Annex II
  • ​MDR and IVDR as pdf - clear, easy to read, with bookmarks (old version only)
  • ​Read our info letter for experts

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