Izabela Chodara

Since 2016, she has been involved in the design, optimization, and testing of medical devices and in vitro diagnostic medical devices. She has participated in various stages of the medical device life cycle, from design and manufacturing to obtaining CE IVD certification. She holds a degree in biotechnology from the Warsaw University of Technology and a degree in clinical research methodology from the Medical University of Warsaw. She is currently enrolled in the MBA program “Health Innovation and Technology” at Łazarski Executive Education. She has experience in conducting clinical trials, performance studies, and analytical studies, as well as in planning them in accordance with Regulations 2017/746 (IVDR), 2017/745 (MDR), and the requirements of other regions of the world. This experience includes designing and supervising studies, as well as preparing documentation in accordance with the principles of good clinical practice and the ISO 20916:2019/ISO 14155:2020 standards. Additionally, she has experience in preparing technical and regulatory documentation for medical devices and coordinating the work of teams involved in the planning and implementation of research and development projects related to the MetTech industry across various therapeutic areas, covering all risk classes.