Day

September 27, 2009
27
Sep

IEC 80002-1 Software Risk TR Published

September 27, 2009
“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...
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