What is IEC TIR 80002-1:2009?

IEC TIR 80002-1:2009 is a technical information report or guidance document that explains how to apply ISO 14971:2019 to medical device software. This applies to both software as a medical device (SaMD) and software in a medical device (SiMD).
If you are looking for the basic software validation requirements, we have another video by Matthew Walker that can help you:
• What is IEC 62304?
If you want to purchase a copy of IEC 62304, we recommend the following website:
www.evs.ee/et/...
If you want to purchase a copy of IEC TIR 80002-1:2009, we recommend purchasing it from AAMI with the AAMI member discount (i.e., $145):
webstore.ansi....