Trying to determine the scope of medical device regulation and whether it applies to a given software platform. The platform provides tools for building chatbots The platform is targeting the Healthcare Domain (providers and payers) The organizations using the platform could build chatbots which answer medical questions or try to perform an initial assessment of their patient's symptoms. The platform has some built-in skills that make this relatively easy to build. Alternatively, the organization could build a chatbot that does nothing medical at all such as looking up opening hours of clinics. Since the intended use for the platform could greatly vary on the organizations use case for the platform I have two questions: Is the creator of the platform within the scope of medical device regulation? EU/US? Is the healthcare organization responsible for complying with medical device regulations also? Some clarity on this would be greatly appreciated.