Design validation is a testing from the market perspective. It is intended to validate whether a medical device is meeting the user’s needs. Successful validation proves that a device meets needs of users in the targeted market. Although validation comes into the picture at a later stage of product development process, it still measures the very first part of the complete process, which is defining user needs. Validation must involve testing and clinical evaluation. Also, it requires a device to be developed in the production environment with an involvement of end-user for actual or simulated testing.
