AAMI has published “AAMI TIR45: 2012 Guidance on the use of AGILE practices in the development of medical device software.” FDA staff was involved in development of this guidance for compliant use of Agile methods. The document can be ordered from AAMI.org.Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.