Risk Management for Medical Devices
In this 2-day course, you will learn about key risk management concepts and get an overview of the process steps involved according to the new ISO 14971:2019. You will also learn how risk management practices should be applied throughout a product’s entire life cycle and how it relates to other processes within a quality management system.
We will highlight specific regulatory requirements that apply to risk management and give you an insight into the increased regulatory focus on risk management in the MDR and the IVDR.
With hands-on exercises, group discussions and examples, this course will provide the knowledge and skills you need to understand and perform each step of the risk management process. The practical part of the course includes an overview of the most common tools used for risk analysis, some best practices for documenting results, and how to ensure traceability.
Topics
- Requirements according to ISO 14971:2019
- Regulatory requirements according to MDR/IVDR
- Key concepts and definitions
- A walk-through of all process steps
- Methods and tools to support risk analysis
- Elements of risk management plan, report, file and traceability
- Integration of risk management into a product’s life cycle and quality management systems