ISO 14971:2019 Risk Management for Medical Devices Training

ISO 14971:2019 Risk Management for Medical Devices Training

ISO 14971:2019 Risk Management for Medical Devices Training

Course Objective:

  • General requirements for risk management system
  • Risk analysis process, Risk evaluation process, Risk control and Evaluation of overall residual risk process
  • Step-by-step of Risk Management Process
  • Development of Risk Management File

Course Highlight:

  • Introduction to ISO 14971
  • Medical device classification
  • ISO 14971 Evolution
  • Overview of the Risk Management Process
  • Management Responsibilities
  • Competence of personnel
  • Hands-on development of a Risk Management Plan & Risk Management File
  • Practical activities to perform the Risk Analysis, Risk Evaluation, Risk Control and Evaluation of Overall Residual Risk
  • Risk Management Review
  • Production and Post-Production Activities

Duration:

1 day or 2 days
 

Suitable for:

Employee whom directly involved in the ISO 13485:2016 Quality Management Systems for Medical Device.

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ISO 14971:2019 Risk Management for Medical Devices Training

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