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, IEC 80001 and IEC ACSEC Guide for Privacy and Security. He was nominated as a US National Expert by AAMI to WG22 of IEC SC62a dealing with programmable systems, to ISO TC210 WG1 dealing with quality systems and to JWG7 of IEC and ISO for Medical IT networks.

He is a member of the AAMI software committee, the AAMI IT committee and the AAMI Cybersecurity 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, medical device cybersecurity, software related regulatory affairs and medical quality systems. He is a member of the US National Council of the International Electro-technical 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 Senior Technical Advisor for Cybersecurity and High Performance Computing.

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. He leads the technical and research aspects of the FDA cybersecurity team. He is active in the internal governance structures of FDA computational science and remains active in both the FDA’s new high performance computing center and semantic text mining activities. He continues to contribute to FDA Guidance development, product review activities and works with several other Federal Regulatory Agencies in the field of cybersecurity.