Regulatory Keynote 2026

Dr. Jenny Stritzel is a medical device regulatory expert with extensive experience spanning medical device development, medical informatics, artificial intelligence, and conformity assessment. Since 2024, she has been working at TÜV SÜD Product Service GmbH, where she serves as Lead Auditor and Technical Documentation and Clinical Evaluation Assessor for active medical devices under the European Medical Device Regulation (MDR). Her responsibilities include auditing according to ISO 13485, MDR, and MDSAP requirements, assessing technical documentation and clinical evaluations, and supporting manufacturers throughout certification processes. She is authorized to evaluate active medical devices and possesses expertise in international regulatory requirements, including those of the United States, Canada, Japan, Brazil, and Australia. Prior to joining TÜV SÜD, Dr. Stritzel worked as a research scientist at the Peter L. Reichertz Institute for Medical Informatics of Technische Universität Braunschweig and Hannover Medical School. Her research focused on medical image analysis, machine learning, clinical decision support systems, and cochlear implant outcome prediction. Her work contributed to several interdisciplinary projects and was recognized with the Best Paper Award at the Medical Informatics Europe (MIE) Conference in 2021. Earlier in her career, she served as a scientific researcher at the Hannover Centre for Optical Technologies, where she developed multimodal imaging systems combining optical coherence tomography (OCT), optoacoustics, and Raman spectroscopy for the non-invasive assessment of melanoma lesions. She also gained industrial experience as a software developer in the field of neuro-monitoring and anesthesia technology. Dr. Stritzel received her B.Sc. in Computational Life Science and her M.Sc. in Mathematics in Medicine and Life Sciences from the University of Lübeck. She earned her Ph.D. (Dr. rer. nat., magna cum laude) in Physics from Leibniz University Hannover in 2023 with a dissertation on model-based simulation and calibration of multimodal imaging systems for melanoma diagnostics. Her professional interests include medical device regulation, clinical evaluation, quality management, artificial intelligence in healthcare, medical imaging, and translational medical technologies.