MedTech Safety
Bio
SPEAKER BIO:
Yu Zhao is the Founder and President of Bridging Consulting LLC, a leading regulatory, quality, and clinical consulting firm that supports AI startups and medical device companies worldwide. Under Yu’s guidance, the firm has grown to include over 25 expert consultants, serving clients across North America, Europe, and Asia Pacific. Since founding Bridging Consulting in 2020, Yu has focused on guiding organizations of all sizes—from early-stage ventures to multinational corporations—through complex regulatory pathways, ensuring they achieve both innovation and compliance.
Yu brings more than three decades of experience in the life sciences and technology sectors, including a 16-year tenure at Medtronic. There, he held multiple leadership roles in regulatory affairs, culminating in positions as director and interim vice president for several multi-billion-dollar business units. Over the course of his career, Yu and his teams have secured more than 150 U.S. FDA approvals and clearances, spanning PMAs, PMA supplements, IDEs, 510(k)s, and De Novos.
Yu holds a BS in Electrical Engineering from Zhejiang University in China, along with an MBA and an MSc from Washington University in St. Louis, Missouri. His extensive background and passion for healthcare innovation drive his commitment to helping companies successfully navigate the rapidly evolving regulatory landscape.