You are a medical device project manager who wants to develop in a modern and agile way while maintaining a design history file in a consistent manner.
You are a RA/QA engineer who wants to keep up with the development team while ensuring the documentation follows your procedures.
You are in a startup and you just discovered that generating the documentation needed for the CE marking or FDA 510(k) will be more complicated than you thought, and you could use some help to streamline that effort.
You are a CEO who wants to manage and control documentation for regulatory approval in a time and cost efficient way.
Or perhaps you are a RA/QA consultant and you work with customers who need to improve their documentation processes...