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AAMI TIR97:2019 (R2023)

Principles for medical device security - Postmarket risk management for device manufacturers

This technical information report (TIR) provides guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. This TIR is intended to be used in conjunction with AAMI TIR57:2016.

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Association for the Advancement of Medical Instrumentation [aami]
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