AAMI TIR97:2019/(R)2023

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

Association for the Advancement of Medical Instrumentation , 09/27/2019

Publisher: AAMI

File Format: PDF

$146.00$293.00


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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