Hello,
I don't suppose someone would be able to give me a concrete definition for "User Needs" as required by the FDA. What I ideally want is to screen user needs requirements to see if they are really a user need and hence require validation. For example, I would argue there is a difference between user "wants" and "needs". For example a user may want something to be easy to use but this isn't necessary a user need.
Thanks.
I don't suppose someone would be able to give me a concrete definition for "User Needs" as required by the FDA. What I ideally want is to screen user needs requirements to see if they are really a user need and hence require validation. For example, I would argue there is a difference between user "wants" and "needs". For example a user may want something to be easy to use but this isn't necessary a user need.
Thanks.