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If you wait to construct a Design Verification plan right before starting verification, this is too late.

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Exciting because yes, to get to Design Verification means that we have accomplished quite a bit.

Terrifying because the work ahead can be frustrating, time consuming, and sometimes ambiguous.

For the reasons described above, a Design Verification Plan is important.

And the time to construct a verification plan is when you define Design Inputs.

To ensure that the product actually meets the user’s needs, and that the specifications were correct in the first place.

In other words, to demonstrate that the product fulfills its intended use when placed in its intended environment.The terms ‘Verification‘ and ‘Validation‘ are frequently used in the software testing world but the meaning of these terms are mostly vague and debatable.You will encounter (or have encountered) all kinds of usage and interpretations of those terms, and it is our humble attempt here to distinguish between them as clearly as possible.There are multiple types of verification and validation: Design, Process, and Software are the most common in the medical device industry. Also, to complicate matters a bit, outside the medical device industry, verification and validation also mean different things.The focus of this post and the relevant terms for Design Controls are Design Verification and Design Validation.Again, there are plenty of times where testing is the only way to verify.

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