The European Medical Device Regulation (MDR) has introduced new requirements for device manufacturers to keep products on the market and launch new products under a challenging transition period. LivaNova has risen to those challenges and developed new products in the Essenz Perfusion System even during the MDR transition. An insider's look into what the MDR means for clinicians, the products they depend on, and what to expect next with upcoming UK regulatory changes.
Julie Leslie, PhD, is an experienced Regulatory Affairs professional with over 15 years in the medical device industry, with 11 years at LivaNova, currently serving as Senior Director of Regulatory Affairs and Clinical for the Cardiopulmonary Business Unit. She has held various leadership roles, including directing Regulatory Affairs for both Cardiopulmonary and Neuromodulation Business Units across global locations in the US and Europe. Her expertise spans product development, clinical evaluation, and managing regulatory teams for cardiovascular, neuromodulation, and heart valve products worldwide.