Validation is important to determine if the device meets the user needs and it’s intended uses, it helps the company determine if they are designing the right device. The FDA heavily focuses on Validation where technically during the entire design controls process of User Needs, Design Inputs, Design Process, Design Outputs, and the final product; Validation is always revisited to see if it achieve’s it’s main intention. As form what we learned from the lecture, Validation is not required if no changes were made after verification, it may not be required technically but it would still be helpful to run a validation report to ensure it continues to meet the user needs and that it did not deviate from the original design.