- Introduction
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Course goals
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Welcome
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Why risk management and what is it - Part 1
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Why risk management and what is it - Part 2
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Quiz - Why risk management and what is it
- Introduction to risk management and tools and techniques
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ISO 14971 vs FMEA
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Quiz - 14971 vs FMEA
- The regulatory background for risk management
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The regulatory background for risk management
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Quiz - The regulatory background for risk management
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The different versions of the standard
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Quiz - The different versions of the standard
- What is new in ISO 14971:2019
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What is new in ISO 14971:2019
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What is new in EN ISO 14971:2019/A11:2021
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Quiz - What is new in EN ISO 14971:2019/A11:2021
- The general requirements of risk management
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Getting to know the standard
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The risk management process
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Quiz - The risk management process
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Calling things by their right names
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Quiz - Calling things by their right names
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Management responsibility and training
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Quiz - Management responsibility and training
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Risk management planning and file
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Quiz - Risk management planning and file
- Risk analysis - From hazard to harm
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When and how to start
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Quiz - When and how to start
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Hazard identification
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Reasonably foreseeable sequence or combinations of events
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Hazardous situations and harm
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Quiz - Hazardous situations and harm
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How to work
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Quiz - How to work
- Risk analysis - Estimating risk
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Probability of occurrence of harm - Part 1
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Probability of occurrence of harm - Part 2
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Severity
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Quiz - Severity
- Risk evaluation
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Risk evaluation
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Quiz - Risk evaluation
- Risk control
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Risk control option analysis - Part 1
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Risk control options analysis - Part 2
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Information for safety and disclosure of residual risk
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Quiz - Information for safety and disclosure of residual risk
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Risk controls and verification
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Quiz - Risk controls and verification
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Estimating the residual risk and benefit
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Residual risk in the EU
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Quiz - Residual risk in the EU
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Using standards as risk controls
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Quiz - Using standards as risk controls
- Overall residual risk acceptability
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Overall residual risk acceptability
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Quiz - Overall residual risk acceptability
- Risk management review
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Risk management review
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Quiz - Risk management review
- Production and post-production activities
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Production and post-production activities
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Quiz - Production and post-production activities
- Usability engineering
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Usability engineering
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Quiz - Usability engineering
- Final exam
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Final Exam - Risk management
- Course evaluation
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Course evaluation
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Conclusion
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Introduction to Risk Management for Medical Devices and ISO 14971
Learn how to effectively apply risk management principles for medical devices during this self paced, interactive online course.
This online course focuses on risk analysis, evaluation and risk control. The course is practical and is suitable for anyone working with risk management, such as R&D and QA engineers, product and application specialists and clinical research specialists.
The course covers an orientation of the risk management process according to the EN ISO 14971:2019 version of the standard as well as the standard’s relation to tools and techniques such as FMEA and P-FMEA.
Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate.
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