The process of ensuring that the device’s specified requirements have been satisfied through inspection and supply of objective evidence is known as verification. Because verification is not an experiment, we must know the answer. The verification process begins with precise and well-defined product criteria, which must be quantifiable in order to be verified.

Several formal protocols govern the technique. It recommends comparing the requirements of the present product to those of previously approved items. The verification procedure must include the entire methodology or a reference to a standardized protocol, as well as a statistical rationale for sample size, a statistical strategy for data analysis, and other information. It should also provide the details of the acceptance criteria as well as the method to take if the verification fails.

A well-defined and incorporated medical device testing plan may assist manufacturers in saving money while also guaranteeing that their products satisfy the requirements of individual consumers. It also reduces the likelihood of a product return. Cooperation with companies that have domain knowledge in testing is encouraged from a business viewpoint since it lowers overall risk and testing time.