ANSI/AAMI/ISO 14971

ANSI/AAMI/ISO 14971 is an international standard that guides manufacturers in managing risks associated with medical devices. It provides a systematic approach to identify hazards, evaluate potential harm, and implement measures to reduce risks to patients, users, and others. The standard ensures that safety considerations are integrated into the design, production, and maintenance of medical devices, helping organizations consistently deliver safe, reliable products that meet regulatory requirements.