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AAMI TIR105:2020
Risk management guidance for combination products
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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]