098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant.

Bijan walks through:

• MedTech vs. Aerospace - Differences in Risk Management Approaches
• Risk Control/Reduction - AFAP vs. ALARP or ALARA and Global Requirements
• Quantifying Benefit and Benefit/Risk
• Risk Control Measures
• What a good risk management process looks

Bijan Elahi has worked in risk management for medical devices for over 29 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 is also teaching a graduate course on medical device risk management at Drexel University (Philadelphia, USA).