IEC 62A and ISO 210 balloting is complete and both approved the work item to initiate project number IEC 80002 Medical device software – Guidance on the application of ISO 14971 to medical device software. The first working group meeting will be in May in Germany. Depending on the direction this work takes it could supplant AAMI TIR 32 which was part of the basis for the work item draft. Several members of the TIR32 working group are involved in this effort including Alan Kusinitz of SoftwareCPR.