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.The development of software begins once the requirements document is 'ready'.One of the objectives of this document is to check whether the delivered software system is acceptable.Exciting because yes, to get to Design Verification means that we have accomplished quite a bit.
Validation is the process of evaluating the final product to check whether the software meets the business needs.Let me share a few perspectives from a recent project.Then I'll get into explaining exactly what Design Verification and Design Validation are, how they are the same, and how they are different. Does the Design Plan specify enough detail (or too much detail)?Producer’s view of quality, in simpler terms means the developers perception of the final product.Consumers view of quality means users perception of final product.In the validation phase, the work products produced as a consequence of requirements engineering are examined for consistency, omissions, and ambiguity.