Bijan Elahi Adjunct Professor School of Biomedical Engineering, Science and Health Systems Email: bijan@medtechsafety.com

Bio

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA). Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

• President - International Council on System Engineering, INCOSE SMC (2003)
• Professional member of: System Safety Society, IEEE

• 4 patents related to kidney dialysis technology -- Baxter Healthcare Corp.
• Patent on a Tachy Detection Enhancement Algorithm – Guidant Corp.
• Patent on deep brain stimulation – Sapiens Steering Brain Stimulation, B.V.

Education

• MS, Electrical Engineering, University of Washington
• BS, Aerospace Engineering with Distinction, Iowa State University
• Continuing education: Systems Engineering; DFSS, Project Management; Training in nephrology, cardiology, electrophysiology, and neurosurgery.

Research Interests

Nephrology, cardiology, electrophysiology, and neurosurgery

Publications

• Whitepaper on Quantification of Benefits for Medical Devices, published in Journal of System Safety; Vol. 58, No. 1 (2023)
• Whitepaper on Management of Risks and Benefits for Medical Devices, published in the Journal of System Safety Vol. 52, No. 1 (2016)

Safety Risk Management for Medical Devices (2nd Edition, 2022) (1st Edition, 2018)