Are you leading or working in a medical or health product development team and struggling to work truly agile inside a waterfall quality management system? Or are you an established medical regulatory professional who feels more and more pressure from the Agile world to adopt their principles and you don’t think this could work? Without holistic consideration, the Agile and Regulatory worlds seem mutually exclusive and coexistence impossible. If this were the case, I probably wouldn’t write this blog post without a valid second thought.