Stine has a master’s degree from the Technical University of Denmark, a PhD within immunology, and more than 10 years of experience with design control and combination products from the medical device and pharmaceutical industry. As a biomedical engineer she has a foundation based on both technical and clinical insight with a focus on user-centered product development. Stine has a solid knowledge of essential requirements and regulatory obligations during medical device development and is experienced in establishing and maintaining design history files throughout all development phases, from concept to post-market surveillance. In addition, she is skilled at working with processes around product development including design control, risk management, and human factors engineering. Besides having a strong analytical mindset and a structured approach, Stine is passionate about working with design input requirements and product risk assessment to support successful design verification and validation and most importantly a safe product that meets user needs and expectations.