In this article is an insightful podcast episode featuring Bijan Elahi, a true leader in medical device risk management with 29+ years of experience at both Fortune 500 companies and innovative startups.
Table of Contents
About Bijan Elahi
Here are some key highlights from his impressive background:
- Technical Fellow & Corporate Advisor on Safety Risk Management at Medtronic
- Lecturer at Eindhoven University of Technology, educating the next generation of engineers
- FDA-invited instructor at Drexel University’s graduate program
- Founder of MedTech Safety, Inc. – has educated over 6,500 professionals worldwide
- Author of “Safety Risk Management for Medical Devices” (Elsevier)
- Active contributor to ISO 14971 international standards
Podcast Episode
The episode dives deep into ISO 14971 and its relationship to ISO 14155, offering valuable insights on risk terminology, clinical study considerations, and best practices that every medical device professional should understand.
Listen Now
For anyone working in medical device development, clinical research, or regulatory affairs – this is essential listening.
The intersection of risk management and clinical investigation is critical for bringing safe, effective devices to market.