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Introducing Bijan Elahi – Medical Products Risk Management Leader and Educator

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We are delighted to welcome Bijan Elahi to the PPI team. Bijan Elahi has authored and will deliver a new PPI course offering to the medical sector: “Medical Products Risk Management”, over three days. The first presentation of this course will be in Eindhoven, NL, over 22-24 November, 2018. See https://www.ppi-int.com/training/mdrm3d/. We hope to see you there!

Bijan Elahi is an expert on a world scale in medical devices risk management and systems engineering. He is the winner of the Educator of the Year Award from the International System Safety Society, for outstanding performance in system safety education. Mr. Elahi’s personal mission is to elevate knowledge and proficiency in medical device risk management to the highest levels via teaching, coaching, and mentoring, to the benefit of companies and society.

He has 25+ years of experience in risk management, working with the largest medical device companies in the world, as well as with small start-ups. He is a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches 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 a graduate-level course in medical device risk management at Delft University of Technology in the Netherlands.

Mr. Elahi is a principal consultant and trainer with Project Performance International.

Mr. Elahi is author of the landmark book “Safety Risk Management for Medical Devices”, published by Elsevier Publishing as Academic Press (3 July 2018). This is the first publication 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 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 – a requirement for all medical devices. See https://www.amazon.co.uk/Safety-Risk-Management-Medical-Devices/dp/0128130989

Mr. Elahi is a Technical Fellow at Medtronic. In this role, he teaches and consults to all Medtronic business units worldwide.

He is a contributor to the international standard ISO 14971-“Medical devices-Application of risk management to medical devices”. He is a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society, and 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.

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.

Mr. Elahi served as the President of the flagship chapter on INCOSE in Seattle. His other memberships include IEEE, and Tau Beta Pi, Engineering Honor Society.

Bijan lives in the Netherlands with his wife Jamie. They have two adult children. Bijan’s interests include cycling, yoga, adventure travel, behavioral economics and critical thinking.

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