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Repeat Solutions Circle
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Fubin Wu, MS

Co-founder & President
GessNet

Fubin Wu is the Co-founder & President of GessNet and the creator of QMSpace, a digital platform that applies assurance-centered, model-based systems engineering to medical product development. QMSpace is powered by out-of-the-box best-practice configurations and a curated digital library to accelerate development with confidence.

With over 30 years of experience, Fubin has supported more than 40 organizations in bringing complex technologies to market, including drug-device combination products, infusion pumps, robotic systems, and Software as a Medical Device (SaMD).

He is known for integrating design controls, risk management, Quality by Design (QbD), cybersecurity, and safety assurance into scalable, lifecycle-resilient systems. Fubin has led the development of more than 30 safety assurance cases submitted to the FDA. Prior to founding GessNet, he held leadership roles at Medtronic and Hospira and began his career as a software engineer at Intel. He holds a master’s degree in Electrical and Computer Engineering from Oregon Health & Science University.

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