Medical Device Risk Management

Wednesday, May 1, 2024

2:30 PM-4:00 PM

BIOMED Seminar

Title:
Medical Device Risk Management

Speaker:
Bijan Elahi
Educator and Advisor
Product Safety and Risk Management
Medtronic

Details:
Safety risk management of medical devices is governed by the international standard: ISO 14971.  Besides understanding the formal requirements of ISO 14971, successful risk management requires the precise use of language as defined in the standard.  Conformance to ISO 14971 is a regulatory requirement, but it also brings many other benefits, which will be discussed.
 
Who should own and lead the performance of risk management?  Typically, Quality Assurance dept. takes on this role.  But this task is better suited to Systems Engineering.  Risk management requires multidisciplinary skills that go beyond the technical aspects.  For example, psychology, philosophy, logic, statistics, and more.  Even culture has an impact on risk management.

Biosketch:
Bijan Elahi has worked in risk management for medical devices for over 30 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 teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. 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, published by Elsevier publishing.

Contact Information

Carolyn Riley
cr63@drexel.edu