ISO 14971: A Step-by-Step Guide to Medical Device Risk Management
This comprehensive course provides a step-by-step guide to medical device risk management, covering the principles and practices of ISO 14971. Participants will receive a certificate upon completion, issued by The Art of Service.Course Features - Interactive and engaging learning experience
- Comprehensive and up-to-date content
- Personalized learning with expert instructors
- Practical and real-world applications
- High-quality content and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking
- Community-driven and mobile-accessible
- Actionable insights and certification upon completion
Course Outline Chapter 1: Introduction to Medical Device Risk Management
Topic 1.1: Overview of ISO 14971
- History and evolution of the standard
- Key principles and concepts
- Relationship with other standards and regulations
Topic 1.2: Risk Management Process
- Risk management framework
- Risk assessment and analysis
- Risk evaluation and control
Chapter 2: Risk Management Planning
Topic 2.1: Establishing the Risk Management Plan
- Defining the scope and objectives
- Identifying the risk management team
- Establishing the risk management process
Topic 2.2: Identifying and Analyzing Hazards
- Hazard identification techniques
- Hazard analysis and risk estimation
- Prioritizing hazards and risks
Chapter 3: Risk Evaluation and Control
Topic 3.1: Evaluating Risks
- Risk evaluation criteria
- Risk evaluation methods
- Comparing risks and prioritizing actions
Topic 3.2: Implementing Risk Controls
- Risk control strategies
- Design and implementation of risk controls
- Verifying and validating risk controls
Chapter 4: Risk Management Review and Update
Topic 4.1: Reviewing and Updating the Risk Management Plan
- Reviewing and updating the risk management plan
- Re-evaluating risks and risk controls
- Updating the risk management report
Topic 4.2: Continuous Improvement
- Identifying opportunities for improvement
- Implementing changes and updates
- Monitoring and reviewing the effectiveness of changes
Chapter 5: Risk Management Report and Documentation
Topic 5.1: Preparing the Risk Management Report
- Content and structure of the risk management report
- Documenting risk management activities
- Reporting risk management results
Topic 5.2: Maintaining Risk Management Records
- Record-keeping requirements
- Storage and retrieval of records
- Protection and confidentiality of records
Chapter 6: Implementation and Integration
Topic 6.1: Implementing the Risk Management Process
- Establishing a risk management culture
- Training and awareness
- Integration with existing processes and systems
Topic 6.2: Integrating Risk Management with Other Processes
- Integration with quality management
- Integration with regulatory compliance
- Integration with other business processes
Chapter 7: Risk Management in Practice
Topic 7.1: Case Studies and Examples
- Real-world examples of risk management in practice
- Lessons learned and best practices
- Applying risk management principles to real-world scenarios
Topic 7.2: Risk Management Tools and Techniques
- Overview of risk management tools and techniques
- Using risk management software and templates
- Developing a risk management toolkit
Chapter 8: Conclusion and Next Steps
Topic 8.1: Summary and Review
- Review of key concepts and takeaways
- Assessment of knowledge and understanding
- Final thoughts and recommendations
Topic 8.2: Continuing Professional Development
- Importance of ongoing learning and professional development
- Resources for further learning and development
- Planning for future risk management activities
Upon completion of this course, participants will receive a certificate issued by The Art of Service, demonstrating their knowledge and understanding of medical device risk management principles and practices. ,
Chapter 1: Introduction to Medical Device Risk Management
Topic 1.1: Overview of ISO 14971
- History and evolution of the standard
- Key principles and concepts
- Relationship with other standards and regulations
Topic 1.2: Risk Management Process
- Risk management framework
- Risk assessment and analysis
- Risk evaluation and control
Chapter 2: Risk Management Planning
Topic 2.1: Establishing the Risk Management Plan
- Defining the scope and objectives
- Identifying the risk management team
- Establishing the risk management process
Topic 2.2: Identifying and Analyzing Hazards
- Hazard identification techniques
- Hazard analysis and risk estimation
- Prioritizing hazards and risks
Chapter 3: Risk Evaluation and Control
Topic 3.1: Evaluating Risks
- Risk evaluation criteria
- Risk evaluation methods
- Comparing risks and prioritizing actions
Topic 3.2: Implementing Risk Controls
- Risk control strategies
- Design and implementation of risk controls
- Verifying and validating risk controls
Chapter 4: Risk Management Review and Update
Topic 4.1: Reviewing and Updating the Risk Management Plan
- Reviewing and updating the risk management plan
- Re-evaluating risks and risk controls
- Updating the risk management report
Topic 4.2: Continuous Improvement
- Identifying opportunities for improvement
- Implementing changes and updates
- Monitoring and reviewing the effectiveness of changes
Chapter 5: Risk Management Report and Documentation
Topic 5.1: Preparing the Risk Management Report
- Content and structure of the risk management report
- Documenting risk management activities
- Reporting risk management results
Topic 5.2: Maintaining Risk Management Records
- Record-keeping requirements
- Storage and retrieval of records
- Protection and confidentiality of records
Chapter 6: Implementation and Integration
Topic 6.1: Implementing the Risk Management Process
- Establishing a risk management culture
- Training and awareness
- Integration with existing processes and systems
Topic 6.2: Integrating Risk Management with Other Processes
- Integration with quality management
- Integration with regulatory compliance
- Integration with other business processes
Chapter 7: Risk Management in Practice
Topic 7.1: Case Studies and Examples
- Real-world examples of risk management in practice
- Lessons learned and best practices
- Applying risk management principles to real-world scenarios
Topic 7.2: Risk Management Tools and Techniques
- Overview of risk management tools and techniques
- Using risk management software and templates
- Developing a risk management toolkit
Chapter 8: Conclusion and Next Steps
Topic 8.1: Summary and Review
- Review of key concepts and takeaways
- Assessment of knowledge and understanding
- Final thoughts and recommendations
Topic 8.2: Continuing Professional Development
- Importance of ongoing learning and professional development
- Resources for further learning and development
- Planning for future risk management activities