This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for …

May 1, 2024 · The definitive guide to ISO 14971 risk management for medical devices. Learn what is expected from regulators & how to leverage risk as a tool.

Risk management by ISO 14971 General The risk management process described in ISO 14971 [1] consists of several steps, as illustrated in Figure 1, which apply to the design, development …

ISO 14971:2019(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of …

Jun 28, 2022 · ISO 14971 is the international standard that defines how to apply risk management to medical devices. The first edition of ISO 14971 was published in 2000. The current iteration …

Nov 7, 2024 · What is ISO 14971? ISO 14971 is the international standard for the application of risk management to medical devices. It outlines a systematic approach for manufacturers to …

Mar 28, 2025 · ISO 14971:2019 is an international standard that guides the application of risk management to medical devices. Manufacturers can use the standard to identify and control …

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

Mar 17, 2025 · ISO 14971 is a globally recognised standard for risk management specific to medical devices. The standard outlines a comprehensive process that helps manufacturers …