ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process.
By the end of this course, you should be able to:
- Recognize the fundamental requirements from medical device regulation relating to risk management
- Explore the ISO 14971 step-wise approach to risk identification, assessment, control and evaluation
- Recognize the importance of risk management planning and a well maintained risk management file
- Identify risk acceptability criteria and apply solutions for your own organization
- Identify key risk control measures to analyze, implement and evaluate risks individually, collectively, and residually to reduce all risks to as low as possible
- Recognize the importance of post-market risk management to the overall process
By completing/passing this course, you will attain the certificate Medical Device Certificate
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