Bijan Elahi is an expert on a world scale in risk management and systems engineering. He was presented with Educator of the Year Award by the International System Safety Society. In 2019 he received another award, this time in recognition of Outstanding Development of Analytical Methods to Support Medical Device System Safety.
Mr. Elahi’s mission is to elevate knowledge and proficiency in medical device risk management to the highest levels worldwide, via teaching, coaching, and mentoring, to the benefit of companies and society. He has 30+ years of experience in risk management, working with the largest medical device companies in the world, as well as with small start-ups. Mr. Elahi has trained over 6,000 people in risk management and his experience in medical devices spans class III implantable medical devices, electro-mechanical and disposable devices. His most recent product was a Deep Brain Stimulator (DBS) implant for Parkinson’s disease.
He is presently a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches a graduate-level course in medical device risk management. The audience for this education is doctoral students in engineering as well as physicians and professionals in the medical device sector. Additionally, Mr. Elahi teaches risk management at Delft University of Technology in the Netherlands and Drexel University in Philadelphia (USA).
Mr. Elahi is a principal consultant and learning facilitator with Project Performance International.
Mr. Elahi is author of the landmark book “Safety Risk Management for Medical Devices”, published by Elsevier Publishing at Academic Press. This is the first published book to focus exclusively on safety risk management of medical devices. The book demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. The book delivers not only on theory, but also a great deal of practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971 – “Application of risk management to medical devices” – a requirement for all medical devices. Mr. Elahi has now authored the second edition of this book. In order to remain consistent with the amended international standards, the second edition includes 6 new chapters, 52 new sections, and updates to 63 existing chapters/sections. See https://www.elsevier.com/books/safety-risk-management-for-medical-devices/elahi/978-0-323-85755-0.
Mr. Elahi is a Technical Fellow at Medtronic. In this role, he teaches and consults on medical device risk management to all Medtronic business units worldwide, including China, India, Middle East, Europe and North America. He is also the Medtronic’s Corporate Advisor on product safety.
Mr. Elahi is a contributor to ISO 14971, and a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society. Mr. Elahi is a frequently invited speaker and lecturer at international conferences. Earlier in his distinguished career, he was a systems engineer on the Space Shuttle at NASA (USA). Mr. Elahi holds an MS Electrical Engineering degree from the University of Washington and a BS Aerospace Engineering degree from Iowa State University, United States.
Mr. Elahi served as the President of the flagship chapter of INCOSE in Seattle, USA. His other memberships include IEEE, and Tau Beta Pi, Engineering Honor Society.
Bijan presently lives in the United States of America with his wife Jamie. They have two adult children. Bijan’s interests include cycling, yoga, adventure travel, behavioral economics and critical thinking.
Courses Presented
- Medical Device Risk Management (2 half-day, 6 half-day or 3 full-day)
