Maxime Kivy - le Bihannic

Maxime Kivy - Le Bihannic holds extensive experience in regulatory affairs and product safety within the medical device industry. Currently serving as Product Safety Manager and Regulatory Affairs Engineer at FX Shoulder Solutions since August 2020, responsibilities include leading regulatory projects, managing compliance for Class III and Class IIa medical devices, and ensuring successful EU MDR certification. Previous roles encompass quality and regulatory leadership at COMEPA and C2F IMPLANTS, where Maxime was involved in CE marking, technical file management, and global product registrations. Ancillary experience includes internships focused on R&D in biomedical engineering and organic synthesis. Maxime possesses a Master's degree in Biomedical Engineering from ISIFC and additional qualifications in mechanical engineering and software development.