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 Kusinitz of SoftwareCPR are instructors for the new AAMI course on Agile methods compliance, Brian was on the working committee that developed TIR45 and Alan was a reviewer. We and our other partners can provide onsite training or help quality system staff and software development groups ensure efficient yet compliant implementation of Agile Methods.