ISO 14971:2019 “Medical devices — Application of risk management to medical devices” defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to production and post production use. The goal of ISO 14971 training is to develop a risk management plan that is capable of assessing, evaluating, identifying controls, and monitoring the risks associated with each life-cycle stage.
- Describe the Risk Management Process as defined in ISO 14971:2019
- Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
- Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
- Identify and Quantify Risks for their Organization
- Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016