Yu Zhao, MBA

Head of FDA & Digital Health Department

Yu Zhao has over 20 years in the medical device industry, including 16 successful years at Medtronic. He held successive leadership roles, including Director and Interim Vice President for several multi-billion-dollar business units. Yu holds B.S. in Electrical Engineering from Zhejiang University in China and MBA and M.Sc. from Washington University in St. Louis, US.
Yu has a proven track record of developing world-class regulatory organizations, advocating before the FDA, NMPA and other regulatory agencies, formulating innovative regulatory strategies and successfully navigating tricky dynamic global medical device regulatory processes. Yu and his associates have obtained more than 150 FDA approvals, including PMAs and PMA supplements, IDEs, 510(k)s and De
Novos. Yu has worked with clients worldwide whose companies range from four-person AI startups to mid-sized companies to the largest global medical device corporation with over 100,000 employees.
Yu’s product expertise includes digital health, mobile apps, clinical decision support (CDS) software, SaMD, SiMD, general health and wellness products, Artificial intelligence (AI) and machine learning (ML) devices, closed-loop systems (e.g., artificial pancreas), and implantable systems (e.g., deep brain stimulation, spinal cord stimulation, and implantable infusion pump). Yu’s functional expertise includes
regulatory strategies, FDA negotiations, QMS, pre and post-market clinical strategies, ad/promo, social media compliance, risk management, and human factors.