ISO 14971 – Risk Management

Description and content:

  1. Description: Comprehensive course on ISO 14971. You will acquire all necessary skill to create, develop and maintain a Risk Management File for medical devices.
  2. Content:
    1. Medical Devices and Risk Management;
    2. Overview of ISO 14971;
    3. The building blocks: risk, safety, hazard, harm, failure and cause;
    4. Scoring: probability and severity: the common framework;
    5. Risk analysis techniques;
    6. Examples and workshop;

Who should attend:

  1. QAs, engineers, developers and managers wishing to learn about the risk management process for medical devices.
  2. Young graduates who want to acquire key knowledge for interviews with Medical Device companies;


Duration: 8 hours
Price per person: 200 €
Min nr of participants: 4


Price per person: 150 €
Min nr of participants: 5

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