ABSTRACT
Validation is needed to demonstrate that the medical device satisfies the user’s requirements and the intended use(s)—i.e., it is a product the marketplace wants and needs. Design validation requirements fall under section 820.30(g) of the Food and Drug Administrations Quality System Regulation and under section 7.3.7 of the ISO 13485 Standard. Planning for validation should begin early in the design and development process. The performance characteristics that are to be assessed should be identified, and validation methods and acceptance criteria established. Depending on the complexity of the device a design validation plan may be developed. Evaluation of any new device intended for human use will require data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks produced by the device materials. The selection and evaluation of materials and devices intended for use in humans requires a method of assessment to establish biocompatibility and safety.
