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Medical device cybersecurity has become very important to the FDA. They have issued two recent guidances on the subject; the latest in December of 2016. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber attacks including involvement with information sharing groups.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.