An Introduction to ISO 14971
Published on: 10/11/2025
ISO 14971 provides a rigorous, systematic framework for the management of risks associated with medical devices.
ISO 14971

ISO 14971 provides a rigorous, systematic framework for the management of risks associated with 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.