This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more.
We presented our approach to implementing agile in an FDA regulated environment to a joint meeting of the Chicago Agile Project Management Group and Health 2.0 Group last week. This is based on our experience developing software for medical devices, and focuses on how to get the benefits of agile development while conforming to FDA regulations.