Co-founder of GessNet, Solutions for Medical Device Safety, Cybersecurity and Regulatory Compliance
Fubin Wu is the Co-Founder of GessNet (http://www.gessnet.com). He architected and led the development of TurboAC™ risk management & assurance case software, in close communications with FDA – Office of Science & Engineering Lab (OSEL) and Office of Device Evaluation (ODE), and in collaboration with AAMI (Association for the Advancement of Medical Instrumentation), infusion pump manufacturers, hospitals, and industry experts. Fubin has spent over 16 years on medical device quality management systems, hardware/software reliability engineering and risk management, serving various roles from quality engineers to quality managers and quality directors, and working on various medical device platforms – implantable devices and remote monitoring systems at Medtronic, infusion pumps at Hospira, and blood management systems at Haemonetics. He managed numerous FDA inspections as the management representative with no 483 observations indicated.
Fubin has a MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU), and was a software developer at Intel prior to his career with the medical device industry.
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