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This document specifies minimum requirements for quality management systems (QMSs) to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and nonmanufacturer- related device failures.
Standard for medical device security—Security risk management for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 12/21/2022
Guidance on the use of agile practices in the development of medical device softwarestandard by Association for the Advancement of...
Water for the processing of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/17/2023
Application of ISO 14971 to machine learning in artificial intelligence—Guidestandard by Association for the Advancement of Medical Instrumentation, 03/14/2023