- Conduct risk analysis and failure mode and effects analysis to identify hazards

- Apply risk analysis methodologies to medical devices

- Learn risk evaluation and risk control principles that affect decision making

- Identify design or process failures and opportunity for development

- Improved risk management

- Program Managers

- Product Managers

- Quality Manager

- Design Engineers

- Manufacturing Engineers

- R&D Managers / Engineers

- Quality Assurance Managers / Engineers

- Management Representatives

- Design Teams

- Design Review Teams

- Project Managers

- Internal and External Auditors

- Knowledge of product design,development or manufacturing

- Knowledge of basic quality assurance concepts

- Expectations of the Food and Drug Administration (FDA) and the EU in applying risk analysis to medical devices

- Risk management requirements and the purpose of ISO 14971

- The application of ISO 14971 to medical devices

- The application of risk analysis methodologies such as FMEA to medical devices

- The principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks

- Sources of information and further development