Understanding ISO 14971:2019 Risk Management
Understanding ISO 14971:2019 Application of Risk Management to Medical Devices - Virtual Training
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Course Duration: 2 Days
This two-day seminar addresses all of the elements of the ISO 14971:2019 Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process. An overview and examples of the Risk Analysis Tools listed in ISO/TR 24971:2019 is also included.
- Explore the specifics of ISO 14971:2019, the Application of risk management to medical devices.
- Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting.
- Provide the competencies needed to introduce new products and processes smoothly with known risks minimized.
- Chapter 1: What is Risk?
- Breakout Exercise 1: Defining Risk for Medical Devices
- Chapter 2: Managing Risk
- Fundamental Risk Concepts
- Risk Management Process
- Management Responsibilities
- Competence of Personnel
- Breakout Exercise 2: Identifying Management Responsibility and Competency of Personnel
- Risk Management Plan
- Risk Management File
- Breakout Exercise 3: Composing a Risk Management Plan
- Chapter 3: Risk Assessment and Analysis
- Risk Assessment
- Risk Analysis Process
- Intended Use and Reasonably Foreseeable Misuse
- Identification of Characteristics Related to Safety
- Identification of Hazards and Hazardous Situations
- Risk Identification Methods
- Risk Estimation
- Breakout Exercise 4: Identifying Risk Elements
- Chapter 4: Risk Analysis Tools
- Preliminary Hazard Analysis
- Fault Tree Analysis
- Event Tree Analysis
- Failure Mode and Effects Analysis (FMEA)
- Hazard and Operability Study (HAZOP)
- Hazard Analysis and Critical Control Point (HACCP)
- Breakout Exercise 5: Using Risk Estimation Techniques
- Chapter 5: Risk Evaluation
- Risk Evaluation
- Risk Acceptability
- Breakout Exercise 6: Identifying Higher Level Risk Elements
- Chapter 6: Risk Treatment and Control
- Risk Control Option Analysis
- Implementation of Risk Control Measures
- Residual Risk Evaluation
- Benefit-Risk Analysis
- Risks Arising from Risk Control Measures
- Completeness of Risk Control
- Breakout Exercise 7: Conducting Risk Control Review
- Chapter 7: Risk Management Monitoring and Reviewing
- Evaluation of Overall Residual Risk
- Risk Management Review
- Production and Post-Production Activities
- Breakout Exercise 8: Conducting Risk Management Review and Overall Residual Risk
Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.
Each participant will receive a seminar manual and a workbook including all team breakout exercises.
No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.