There is no doubt that agile is an accepted development methodology. However, if you work in a regulated industry like health care where you have to comply with its standard operating procedures, heaps of paperwork, and frequent audits, don’t these conflict with agile’s core tenets? Chris Ampenberger describes his operating environment and the applicable regulations that define the constraints for the software development process he can use. He shares how they overcame the incongruity between agile and regulatory requirements.