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AAMI/ISO TIR80002-2:2017

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

Summary

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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2017
Page Count 103
Themes IT, Software, and Wireless
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