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MedTech Safety

Bio

Fubin Wu is the co-founder of GessNet, a leading company specializing in best-practice software solutions and expert consulting for medical product lifecycle management. He led the development of QMSpace, an integrated solution for design controls, risk management, Quality by Design (QbD), cybersecurity, and safety assurance cases, as well as TurboAC, a global risk management and safety assurance case software solution.

With over 30 years of experience, Fubin has worked with more than 40 clients, from startups to global industry leaders, on the development of cutting-edge medical products. His expertise spans drug-device combination products, infusion pumps, SAMS (Smart and Autonomous Medical Systems), implantable devices, patient monitoring technologies, robotic surgery systems, and SaMD (Software as a Medical Device).

A distinguished instructor and speaker, Fubin is recognized for his expertise in risk management, drug-device integration, safety engineering, cybersecurity, and software reliability. He has led the creation of over 30 safety assurance cases for drug delivery products, successfully demonstrating their safety and effectiveness to the FDA.

Before founding GessNet in 2011, Fubin held leadership roles at Medtronic and Hospira, where he served as Quality Director and Manager. He began his career as a software developer at Intel.

Fubin holds a Master’s degree in Electrical and Computer Engineering from Oregon Health & Science University.
 

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