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User Needs - Concrete definition for "User Needs" as required by the FDA

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  Post Number #1  
Old 14th June 2018, 04:25 PM
david316

 
 
Total Posts: 31
Thank You! User Needs - Concrete definition for "User Needs" as required by the FDA

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.

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  Post Number #2  
Old 15th June 2018, 12:55 AM
sagai

 
 
Total Posts: 1,133
Re: User Needs - Concrete definition for "User Needs" as required by the FDA

That's actually a non-functional user needs for me with a potential to refine it further being easy to digest by engineering.
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  Post Number #3  
Old 15th June 2018, 10:15 AM
yodon

 
 
Total Posts: 1,166
Re: User Needs - Concrete definition for "User Needs" as required by the FDA

We typically have a 'Product Requirements' or 'Marketing Requirements' type document that covers user needs. These are, though, framed as "shalls" and they form the basis for validation. So, indeed, there are typically no "wants" in there. As sagai notes, these requirements are then elaborated as system requirements which is "engineering's answer" to the user needs (with appropriate tracing between the sets).
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