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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.

The device is an electronic medical device with firmware. So here we were, about to begin Design Verification. Regardless, let's now get into the specifics of Design Verification and Design Validation that the startup CEO didn't want to.

Early design and development activities were trying. Lots of back and forth, with seemingly little to no progress at times. We had a loosely defined plan for all the Design Verification activities. While we were addressing Design Verification, the startup CEO only heard that we were preparing the 510(k), which in his mind was more meaningful and significant. Let me dive into explaining what they are, how they are the same, and how they are different.

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