Technical sessions and workshops
Short course: Introduction to Medical Device Safety Risk Management (ISO 14971)
Overview
Medical device safety is governed by a structured and rigorous approach to risk management. This short course provides a practical introduction to the principles of safety risk management for medical devices, in conformance with ISO 14971.
Designed for engineers, researchers, and professionals interested in safety-critical systems, the session offers a clear and accessible foundation in how safety risks are identified, analyzed, and controlled in the medical device industry.
What You Will Learn
- The fundamentals and vocabulary of safety risk management
- What it means to manage safety risks in practice
- The governing standards for medical device safety, with emphasis on ISO 14971
- Core elements of the risk management process: hazard identification, risk estimation, evaluation, and control
- Industry best practices in applying risk management
- Practical tips and guidance for successful implementation
Format
Interactive lecture with practical examples and discussion
Duration: 2 hour
Date: Monday, 15th June - 14:45-17:30
Course Fee
€249 (includes certificate of attendance and course materials)
Instructor
Bijan Elahi is an award-winning international educator, consultant, and author with over 30 years of experience in medical device risk management. He is a Technical Fellow and Affiliate Professor at Drexel University, and a lecturer at Eindhoven University of Technology. He has trained over 10,000 professionals worldwide, is acontributor to ISO 14971, and is the author of the best-selling book 'Safety Risk Management for Medical Devices' (Elsevier).
This short course, including all its content, is the sole responsibility of the lecturers. Neither ESREL2026 nor ESRA assumes any responsibility or liability for the content, accuracy, or opinions expressed in this course.