Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials.
In this episode, you’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good Clinical Practice.
You’ll also understand key terminology around risks, how to define risk, what’s special about clinical studies with respect to risk management, and much more.
Bijan 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 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 also teaches a graduate course on medical device risk management at Drexel University in Philadelphia.
Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide.
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.
Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing.
This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. To learn more, visit slope.io