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Old 15th June 2011, 03:47 PM

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Re: Design Input/Output and Design V&V (Verification and Validation) Interpretations

Thanks Gholland for your reply. I agree with what you say - validation is also about demonstrating that the device meets the user needs, in addition to intended use(s).

As I understand the literature on Design controls, user needs + intended use(s) are expressed as (organized into) testable design input requirements (the "what", written in a language that all stakeholders can understand), such as "the device must tolerate being used in xxx environment for the stated period of time" (similar to your example). Specifications are the "how" (translated from requirements), and are typically concept-dependent. The link between requirements and user needs is called requirements validation. The link between implementation and requirements is called design validation.

What do you think? Any comments anyone?

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