About Course
Course Duration: 2 Days – 8 Hours/day
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.
Course Outline
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
