Medical software systems already have legal obligations that fall on (I believe) the CEO of a firm. In the CRO space for clinical trials for example you're ofte

Medical software systems already have legal obligations that fall on (I believe) the CEO of a firm. In the CRO space for clinical trials for example you're often audited by the FDA, MHRA, and others to ensure your processes are documented and followed, your issues traced and corrected, etc. You also have a requirement to fulfil things like 21 CFR Part 11 for records and signatures tracking/management. Failures of a company responsible for this kind of thing that lead to injuries or deaths can result in imprisonment of (at least) the CEO and possibly others. I'm not sure licensing is necessary here, that's what documented process is supposed to manage (change tracking, development process, etc.)