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Scope vs Design Controls verification

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Scope verification is the acceptance of the project scope. This is different than the design controls verification. What are the differences between the two?

Posted : 08/03/2022 9:48 pm
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Put simply, design controls are a formalized approach that a company needs to follow the safety and efficacy of the device to the FDA. These are somewhat consistent between projects, depending on the class of the device. User needs, Design Inputs and Outputs, Design Verification and Validation are just a few basic examples of design controls that need to be met.

Based on what I took from the lecture, scope verification is when you take a sort of "bird's eye view" of your project and see if you are getting the desired outputs based off your inputs. For example, if your device needs to accurately measure blood pressure within a certain window of time, does it meet those expectations or does it take longer to get an accurate reading? And if so, is there a way to optimize your product to have it meet those expectations? If not, you would probably want to revisit your scope and make the proper adjustments.

That is my interpretation of scope verification and how it is different from design control verification, but please feel free to correct me if I am mistaken.

Posted : 09/03/2022 4:26 pm