We are able to present tailor-made workshops for your organization on all topics in the field of regulatory affairs and quality management systems for medical device manufacturers.

Workshops can be presented in German or English. We are happy to run the workshop on your premises or in our workshop center in Germering near Munich. Herewith an excerpt of workshops that we offer:

  • Design and structure of technical documentation
  • Automatic updating of technical documentation according to Regulation (EU) 2017/745 (MDR)
  • Establishment of a risk management process
  • Establishment of a post-market surveillance process
  • Establishment of a change management process
  • Establishment of a medical device development process
  • Creating a Clinical Evaluation according to MEDDV 2.7-1 Rev. 4
  • Selection and research of national and international regulatory requirements
  • Training as an internal auditor for your own organization
  • Regulatory requirements for active medical devices
  • Regulatory requirements for non-active medical devices
  • Performing a process validation
  • Analysis of processes and optimization
  • and many more…

Please feel free to contact us. We will gladly provide competent and individual advice.