Module 6 teaches the purpose, methodology and regulation of medical device risk identification, assessment and mitigation. The module includes a comprehensive study of usability regulation, assessment and risk assessment.
Learning objectives
- To understand risk management and risk based approach within the lifecycle of a medical device
- To understand the requirements of the risk management process
- To know how to perform Risk Management activities write risk management documents
- To understand Usability principles and to know how to analyse potential usability risks
Learning content
- The standards for risk management in medical devices
- Risk based approach – parallel with ISO 13485 and Medical Device Regulation
- Risk management Planning
- Risk management in the design phases, Hazard identification, establishing severity, probability and the risk matrix
- Risk Control measures – how can we reduce risk?
- Techniques for risk analysis and risk management for production processes
- Risk Management in post market phases including change management
- Usability engineering standards for medical devices and designing usability Engineering studies
