Design validation

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== Definition of design validation ==
 
== Definition of design validation ==
  
According to the FDA, “Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).“. This definition can be traced back to the ISO 9001:1994 standard. Simply put, validating a design means answering the following question: did you design the right product?  
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According to the FDA, “Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).“. Simply put, validating a design means answering the following question: did you design the right product?  
  
== Difference with verification
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== Difference with verification ==
  
 
Verification is linked to validation, but its goal is to make sure that the product works. It answers the question: did you deisgn the product right.
 
Verification is linked to validation, but its goal is to make sure that the product works. It answers the question: did you deisgn the product right.

Revision as of 13:45, 18 February 2022

Contents

Abstract

The Ford company realized in 1957 that making a perfectly functional car was not enough to achieve commercial success. Indeed, nobody wanted to buy it, and the company suffered a loss of 250 million dollars [1]. The goal of validation is to ensure that a design meets the user's needs, and it is just as important as producing a functional design. Indeed, an inadequate validation will result in designing an undesired or unsuitable product, wasting significant amounts of resources, money, and time. The increase in complexity and duration of design projects often causes the initial objectives to get forgotten. Validation closes the production loop and ensures that the functionality intended for the user is fulfilled. Traditionally, validation is performed at the end of the product design process, through direct user testing, among other methods. However, a newer validation approach is called User-Centered Design and consists of early user integration in the design process, which spreads the validation over the whole project timeline.


Big Idea

Definition of design validation

According to the FDA, “Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).“. Simply put, validating a design means answering the following question: did you design the right product?

Difference with verification

Verification is linked to validation, but its goal is to make sure that the product works. It answers the question: did you deisgn the product right.

Application

Limitations

Reference

  1. Bahill, A. T., & Henderson, S. J. (2005). Requirements Development, Verification, and Validation Exhibited in Famous Failures. Www.Interscience.Wiley.Com). Syst Eng, 8, 1–14. https://doi.org/10.1002/sys.20017
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