In the medical sector, regulations are omnipresent. These are not necessarily up to date, and drive digital medical device manufacturers to use V-cycle rather than Agile methods. Today, it has been successfully demonstrated that Agile methods can be used to comply with regulations in software development. But what about when it comes to producing the evidence needed to obtain CE marking to market these devices?

In this talk, I'll be presenting solutions and examples of how we can agilely respond to normative and regulatory requirements, over and above the simple development of a digital solution. The rigid system we have to follow can ultimately be made more flexible with the right tools.