ISO 14971 Risk Management

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.

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