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 the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.

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

a new edition of EN ISO 14971, and the guidance report will be adopted as CEN ISO/TR 24971. Annexes Z have been prepared, such that EN ISO 14971:2019 can be harmonized under the European Directives 90/385/EEC [3] for active implantable medical devices (AIMDD), 93/42/EEC [4] for medical devices (MDD) and 98/79/EC [5] for in vitro diagnostic ...

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 is the third edition and was released in 2019.

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 assess the risks associated with medical devices, from design and development to production and post-market monitoring.

[SOURCE: ISO/IEC Guide 63:2019, 3.4] environment, indication, patient operating principle are typical elements of the population, part of the body or type of tissue interacted intended use.

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 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 risks associated with their products to ensure the safety of patients, users, and third parties.

Apr 15, 2024 · ISO 14971:2019 Medical devices — Application of risk management to medical devices specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.