The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verification protocol. This requires one to know their product’s shape, function, dimensions, specifications and FDA/governmental regulations that a product may face and finding the appropriate methods for testing each of these specs ahead of time. This is done to ensure that a product will turn out the way it was intended. Therefore the best time to carry out verification is when all of these factors have been accounted for (assuming your inputs are flawless). As learned in lecture; the verification report must also be prepared to address any failed test results so that the validation can be facilitated.

The ideal time to carry out design validation is when a clinical testing protocol has been formulated (or simpler testing methods assuming a low-risk device). This is an important stage that must be properly timed since it ascertains whether the product is compatible with the user or not. This phase should not be rushed by any means since making any changes at this point may have a more costly outcome since validation is one of the later stages of the design process. If one is lucky with a low-risk device, then there may not be a need for validation at all.

One of the most important factors required for both design verification and validation is to have foreknowledge of how big the sample size will be for all testings to be done. Too few samples can lead to skewed/inaccurate data while too many samples may waste resources. How do sample groups differ between verification and validation? What other similarities do verification and validation share? These two processes often get confused, what could possibly go wrong if for example, clinical trials are carried out during the verification step for the design of a pacemaker?