Software development within regulated settings is becoming more and more common place. Compliance typically involves saying what you do and doing what you say. However, in some domains, especially safety-critical ones, it needs to be more than simply following the rules, and should be something which everybody in the organisation supports in their daily tasks. This can be difficult to achieve and requires an organisational transformation, but once begun, sets the foundation on which the software development process can evolve. © 2013 Springer-Verlag.