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Guidelines
Deadline 18/06/2026 09:53:00 UTC+1
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 hours
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