In part 1 of our 2023 State of Medtech Design and Development Report we discussed sensors, AI and the paradigm…
Design verification and validation is often completed through physical testing, but can also include other methods such as inspections, review of specifications, or analysis of materials.
Section 21 CFR 820.3 of the federal code defines design verification as “the process of confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is defined as “the process of establishing by objective evidence that product specifications conform with user needs and intended use(s).”
The goal of verification is to ensure there is sufficient evidence that a new medical technology or device has met all engineering requirements (design inputs). Design validation ensures the product’s design output meets identified user needs. User needs can be validated in different ways including usability studies, short or long preclinical studies, and clinical trials. These typically evaluate the user’s interaction with the device, or its comprehensive functional performance.