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ISO 14971 – RISK MANAGEMENT

FROM 150 €
8 HOURS
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;

 

MINIMUM 5 PARTICIPANTS (150€ / PERSON)

FROM 150 €
8 HOURS
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