What ISO 14971 does not apply to ?

ISO 14971 is an international standard that provides a framework for managing risks associated with medical devices. It is important to note that the U.S. Food and Drug Administration (FDA) recognizes ISO 14971 as a standard for medical devices.

ISO 14971 is used to ensure the safety and effectiveness of medical devices by providing a systematic and comprehensive approach to risk management throughout the product's lifecycle. It outlines the process of identifying, analyzing, and controlling potential risks associated with medical devices, including potential harm to patients and users.

ISO 14971 is an important standard for medical devices because it helps to ensure that medical devices are safe and effective for use. It also helps to identify potential risks associated with medical devices and allows for the development of strategies for minimizing those risks.

ISO 14971 is not only used by medical device manufacturers but also by regulatory agencies, such as the FDA, to ensure that medical devices are safe and effective for use in the market.

In conclusion, ISO 14971 is an important international standard for medical devices, as it helps to ensure the safety and effectiveness of these products and allows for the development of strategies for minimizing potential risks. The FDA recognizes ISO 14971 as a standard for medical devices, and it is used to identify, analyze, and control potential risks associated with medical devices throughout their lifecycle.