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December 20, 2013
AAMI announced that TIR45-2012 “Guidance on the use of agile practices in the development of medical device software” was their most popular TIR for 2013. This document was developed with the participation of FDA and addresses how Agile Methods can be use in compliance with FDA medical device regulations for software. Brian Pate and Alan...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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