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Old 9th June 2011, 04:44 PM
Marc's Avatar

Total Posts: 26,354
I Say... Re: Design Input/Output and Design V&V (Verification and Validation) Interpretations

In Reply to Parent Post by dweebie View Post

<snip> "design validation is really what happens near the end of the design or redesign of a medical device, it is done as a set of various activities to answer the question, does this design solution actually perform and function as I intend it to and does it meet my user needs. Design verification activities provide theoretical assurance that the design is appropriate in regards to your defined design input requirements, design validation provides evidence beyond theoretical that the device you designed is truly safe and effective within the context of those same design input requirements". <snip>
Yup - That's it in a nutshell.

Verification = Theoretical (the old "According to my calculations...")
Validation = Actual as determined by testing (often done on a prototype, but in some cases validation is done through actual use - depends upon the product and the industry).

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