Dr. Luise Fuhr joined Kalms Consulting as a Consultant in 2023. She holds a Bachelor of Science in Biology and a Master of Science in Molecular Life Sciences from the Free University Berlin and Humboldt University Berlin, respectively. In 2019 she finished her Ph.D. (Dr. rer. nat.) in Molecular Biology with focus on the circadian clock and molecular cancer research and continued her work in the field as a Post Doc. She gained scientific experience in various multidisciplinary research projects and proved her ability to work effectively and independently. During her Post Doc she had the possibility to change perspectives and was involved in the setup of a QMS according to ISO 13485 for an IVD developed at the Charité. With her knowledge she supports medical device manufacturers to gain regulatory compliance from development to product-specific technical documentation at Kalms Consulting. Furthermore, she is author of several publications in high-impact scientific journals preparing her for the assessment and analysis of scientific literature for regulatory compliance and market access activities. Her background in molecular biology furthermore enables her to assess medical technology especially in the diagnostic field.