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AAMI/ISO TIR80002-2:2017

Medical device software - Part 2: Validation of software for medical device quality systems

This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

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Association for the Advancement of Medical Instrumentation [aami]

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