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Provides guidance to manufacturers that change existing or create new alarm systemalgorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence.
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