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)