Nika Mendelev is a Medical Devices Compliance Expert specializing in Software as a Medical Device (SaMD) and AI-based applications. Expert in navigating global regulatory frameworks to ensure innovative and compliant product development. at AR2-C2 GmbH. They is proficient in German and English. Colleagues describe them as "I worked together with Nika in Cardiovascular group at IBMI. She was an important part of our team. Nika successfully manage technical projects alone as well as part of a team. She is experienced user of LabView and Matlab and very communicative person." and "Dr. Nika Rudelman was a visiting scientist in our laboratory, and was instrumental in developing the very first intravascular near-infrared fluorescence imaging system. Her efforts have lead to revolutionary approach to image biology in human coronary arteries. Nika worked efficiently on her own, and worked extremely well in a team environment. She possesses excellent engineering, analytical and computational abilities. It is a pleasure to write in support of her. --Farouc Jaffer, MD, PhD Principal Investigator, Cardiovascular Research Center Cardiology Division, Massachusetts General Hospital Assistant Professor of Medicine, Harvard Medical School"