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AAMI/ISO TIR80002-2:2017

AAMI/ISO TIR80002-2:2017

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

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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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