ABOUT US

We offer several courses on risk management in compliance with ISO 14971.  You will gain practical, beneficial knowledge and skills that you can put to use immediately.   Learn how to do risk management in a sensible efficient way and produce great submissions. 

Bijan Elahi

Educator & Advisor

Bijan Elahi has worked in safety risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry. Passionate about risk management, Bijan has trained over 10,000 people worldwide, on the best practices and knowledge on medical device safety risk management.

Bijan is a technical fellow and corporate advisor on product safety risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Drexel University in the USA, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. 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.

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