Steven Yue is a seasoned professional with over 25 years of expertise in quality management, regulatory compliance, and medical device standards. Throughout his career, he has worked across biotech, pharma, and medical devices, excelling in areas such as GMP audits, FDA remediation, and ensuring compliance for complex product portfolios. Steven is particularly skilled in managing quality systems for advanced therapies, biologics, and medical devices, having played a pivotal role in achieving ISO 13485 certification and EU MDR compliance.

At B Squared, Steven brings a meticulous, solutions-driven approach to support clients in navigating the complexities of regulatory environments and supply chain operations. Beyond his professional accomplishments, Steven enjoys classic cars, tennis, and cooking—combining precision and creativity in all aspects of life.