• 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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