Über die Veranstaltung

Keywords:
- Standard ISO 14971:2019
- Risk acceptance criteria
- The risk management process
- Risk management in the product life cycle
- Risk analysis & risk control
- Risk management review
- Post market surveillance
- Exercises: Risk management lifecycle
Description:
This course provides a comprehensive overview of risk management for medical devices in accordance with ISO 14971:2019, including risk acceptance criteria and the structured risk management process. Participants will explore risk analysis, risk control, risk management reviews, and the integration of risk management throughout the entire product lifecycle, including post-market surveillance. Practical exercises on the risk management lifecycle reinforce key concepts and support effective implementation in real-world scenarios.