Risk Management for Clinical Investigators with Bijan Elahi

<p><span style="font-weight: 400;">This is a special episode on risk management.</span> <span style="font-weight: 400;">It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development.</span> <span style= "font-weight: 400;">This episode serves exactly that purpose.</span></p> <p><span style="font-weight: 400;">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.</span></p> <p><span style="font-weight: 400;">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.</span></p> <p><span style="font-weight: 400;">Our guest today is Bijan Elahi.</span></p> <p><span style="font-weight: 400;">Bijan has worked in risk management for medical devices for over 29 years at the l</span><span style="font-weight: 400;">argest medical device companies in the world, as well as small startups. </span><span style="font-weight: 400;">He is a technical fellow and Medtronic corporate advisor on safety risk management of.</span> <span style="font-weight: 400;">medical devices. </span></p> <p><span style="font-weight: 400;">In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. </span></p> <p><span style="font-weight: 400;">Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering.</span> <span style= "font-weight: 400;">At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia.</span></p> <p><span style="font-weight: 400;">Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide.