Application of Risk Management to Medical Devices ISO 14971
Published on: 26/10/2025
ISO 14971 provides the scientific and regulatory foundation for managing risk throughout the lifecycle of medical devices.
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ISO 14971 provides the scientific and regulatory foundation for managing risk throughout the lifecycle of medical devices.

ISO 14971:2019 provides a structured framework for identifying hazards, assessing and controlling risks, and monitoring the effectiveness of risk mitigation measures throughout the device lifecycle.