Fubin Wu MS GessNet

Fubin Wu is the Co-founder & President of GessNet. With 25+ years of experience, he has guided 40+ global organizations in bringing diverse medical technologies to market—including drug-device combination products, infusion pumps, robotics, and SaMD—and has led 30+ safety assurance cases submitted to the FDA. He is also a recognized instructor, curriculum designer, and international speaker, having developed and delivered training for PDA, ISPE, RAPS, AAMI, and FDAnews. His teaching focuses on translating complex technical, quality, and regulatory challenges into case-based, applied learning experiences. Fubin is the creator of QMSpace, a CGMP-compliant digital platform providing a single source of truth for medical product development and lifecycle management. Powered by digital libraries, QMSpace integrates design controls, risk management, Quality by Design, cybersecurity, and safety assurance cases into one model-based system—enabling organizations to maximize reuse, accelerate innovation, ensure safety and compliance, and manage lifecycle change with confidence.