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BME 302 Final Exam Study Guide Solutions

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BME 302 Final Exam Study Guide Solutions Requirement [Definition] - ANSWER-customer need which must be met Specification [Definition] - ANSWER-technical description of how a given requirement will be satisfied. Quality [Definition] - ANSWER-the totality of features and characteristics of a p...

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  • November 3, 2024
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BME 302 Final Exam Study Guide

Solutions


Requirement


[Definition] - ANSWER✔✔-customer need which must be met


Specification


[Definition] - ANSWER✔✔-technical description of how a given requirement will be satisfied.


Quality


[Definition] - ANSWER✔✔-the totality of features and characteristics of a product or service that bears

on its ability to satisfy stated or implied needs.


Quality System


[Definition] - ANSWER✔✔-organizational structure, responsibilities, procedures, processes, and

resources for implementing quality management.


Verification


[Definition] - ANSWER✔✔-confirmation by examination and provision of evidence that specified

requirements have been fulfilled.

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Validation


[Definition] - ANSWER✔✔-confirmation by examination and provision of objective evidence that the

particular requirements for a specific intended use can be consistently fulfilled.


What question do you ask to see if a device is Verified? - ANSWER✔✔-"Does the device meet

specifications?"


What question do you ask to see if a device is Validated? - ANSWER✔✔-"Does the specification satisfy

the requirement and meet the user's need?"


User Needs inform the _____ _____.


[2 Words] - ANSWER✔✔-design inputs


What questions do you ask at the User Needs step? - ANSWER✔✔-- Who are your users?




- What do your users want you to design?




- What are the overarching design goals?


Design Input - Constraint


[Definition] - ANSWER✔✔-a limit or restriction on the design's behaviors or attributes.


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Design Input - Function


[Definition] - ANSWER✔✔-a specific thing a designed device or system is expected to do.


Design Input - Specification


[Definition] - ANSWER✔✔-a scale on which the achievement of a design's functions can be measured.


What happens in the Design Process step? - ANSWER✔✔-You consider multiple design options that

could meet the specified constraints and specifications.


What questions do you ask at the Design Process step? - ANSWER✔✔-- How well do the design options

fit within the constraints of the design problem?




- How well might these design options perform in reality? Will they meet the specifications?


What is the purpose of the Design Output step? - ANSWER✔✔-Informs how you fabricate the device for

testing.


What guides the Design Output step? - ANSWER✔✔-Specifications


What question do you ask in the Design Output step? - ANSWER✔✔-Is your process and information

fully documenting the finalized design?


How is a product evaluated during the Verification step? - ANSWER✔✔-Ensured it was built according to

the Requirements and Design Specifications.

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