Kerstin Stöffler

Characterised by a very high level of commitment and initiative as well as goal-oriented work, I put a lot of heart and soul into the tasks assigned to me. I also place great importance on being both reliable and helpful.

  • B. Eng. Medical Technology, M. Sc. Biomedical Engineering
  • more than 6 years experience in the development, testing and approval of medical devices and medicinal products
  • Experience in the preparation of technical documentation and the submission of regulatory documents in accordance with EU MDR
  • Knowledge of medical device approval in the U.S., including 510(k)
  • Experience in the preparation of pharmaceutical quality and marketing authorisation documents in projects
  • Assistance in planning validation activities to ensure regulatory compliance of medicinal products
  • Independent and practical responsibilities in testing laboratories (mechanical and analytical testing)