Sarah graduated as a M.Sc. in biomedical engineer from the Technical University of Denmark (DTU) in February 2021. Prior to this she did a Bachelor of Engineering in healthcare technology. Sarah has therefore a great combination of understanding the theory and being able to use it in practice. Sarah works structured and is ready to make an extra effort to reach goal. Both her bachelor engineering project and master thesis had an angle on the transformation from Medical Device Directive (MDD) to Medical Device Regulation (MDR) regarding classification of medical devices and the eventually belonging software. More specific her bachelor engineering project dealt with developing an ECG-sound reproduction system and how it should be legalized. Therefore, Sarah has a great background knowledge in user requirements and need, the eventually risks and a technical insight. As a Design Control Specialist, she will contribute with her interdisciplinary knowledge, as she understands the aspects behind the technical part of the developing, which strengthen her work with both risk management and the user’s needs.