ISO 14971 is an international standard that specifies the requirements for risk management of medical devices. The standard was developed by the International Organization for Standardization (ISO) and provides guidance on how to identify, analyze, evaluate, control, and monitor risks associated with medical devices throughout their lifecycle.
ISO 14971 is intended to be applied by medical device manufacturers, designers, regulators, and other stakeholders involved in the medical device industry. The standard emphasizes the importance of risk management in ensuring the safety and effectiveness of medical devices and provides a systematic approach to managing risks throughout the product development process.
ISO 14971 is widely recognized and accepted as a best practice for medical device risk management and is often used as a basis for regulatory compliance in many countries. Compliance with ISO 14971 is generally required for medical device manufacturers seeking to obtain regulatory approval to market their products in the United States and the European Union.