Software and Cybersecurity Risk Management for Medical Devices
Fubin Wu is the Co-Founder of GessNet. GessNet is a software and consulting company specializing in medical device risk management (www.GessNet.com). He designed and led the development of TurboAC™ risk management and assurance case software, in concert with the FDA, Association for the Advancement of Medical Instrumentation (AAMI), medical device manufacturers, hospitals and industry experts. Mr. Wu has spent more than 16 years in medical device quality management systems, hardware/software reliability engineering and risk management, serving various roles from quality engineer to quality director. Additionally he has worked 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 a management representative with no 483 observations indicated. He has an 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.
Lisa Simone, Ph.D., Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA
Lisa Simone works for the FDA as Software Engineering Team Lead and Policy Advisor in the Office of Blood and Research and Review in the Center for Biologics Evaluation and Research (CBER). In this role she leads the software group in review of devices including blood donor screening tests, retroviral diagnostic tests, and software used to test, collect, process, or store donated blood. Dr. Simone also leads the development and review of policy for software in regulated devices.