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ISO 14971:2019 Risk Management for Medical Devices Training
ISO 14971:2019 Risk Management for Medical Devices Training
Category: Medical Devices QMS Related 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 daysSuitable for:
Employee whom directly involved in the ISO 13485:2016 Quality Management Systems for Medical Device.Contact us for the synopsis.
ISO 14971:2019 Risk Management for Medical Devices Training
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