University of Minnesota
Software Engineering Center

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Brian Fitzgerald


Brian Fitzgerald was educated in England and received his engineering degree from University College Cardiff in Wales. He became a US citizen in 2003.

He left the private sector in 1992 after a multidisciplinary engineering career, and joined Underwriters Laboratories (UL) in Raleigh, NC helping to start their software safety initiative. He has contributed to the development of several national and international standards for programmable systems UL 1998, IEC 60601-1-4, AAMI SW68 and most recently IEC 62034. He was nominated as a US National Expert by AAMI to WG22 of IEC SC62a dealing with programmable systems and to ISO TC210 WG1 dealing with quality systems.

He is a member of the AAMI software committee. Prior to joining FDA he was an accredited software expert and lead auditor for two European notified bodies. He continues to conduct public seminars in software safety, risk management, 21 CFR Part 11, cybersecurity, software related regulatory affairs and medical quality systems. He is a member of the US National Council of the International Electrotechnical Commission.

He joined FDA’s CDRH in October 2003 in the Office of Science and Engineering Laboratories to specialize in systems, software evaluation and safety research activities. He is currently Deputy Director of the Division of Electrical and Software Engineering.

Current projects include researching the use of formal methods as they relate to generalized 'assurance cases' including safety cases and compliance cases, and the development of forensic techniques for detecting and investigating software failure. Mr. Fitzgerald continues his standards development activities and has been instrumental in the development of the recent FDA guidance on Cybersecurity in medical devices and FDA regulations.