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This technical information report provides recommendations and processes to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.
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