Software is software is software, right?
That’s what Jose Bohorquez and I hear from medical device companies all the time.
Software for medical devices and software as a medical device are subject to very extensive and detailed regulatory requirements.
Dozens and dozens of regulations. Pages and pages of guidance, and 60-page documents that explain the guidance.
So, no. Not all software is created equal, and there is a LOT you need to be aware of when developing for a medical device: https://www.youtube.com/watch?v=p5sqr2J0o8g
