Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification should start at an early stage when design input are developed. If process of proving that medical device is correctly designed starts at an early stage then Design output meets design input during the formal design verification. Design verification is an important part of regulatory submissions . Regulators needs the evidence that medical device is safe and satisfies all requirement. Spend more time in defining the design input so that design verification gets easier.
Design Validation is a Design Controls activity that happens late in the product development .This is the stage where you actually build a version of the product and validate against the user requirements. The process of validation generally occurs as one step or multiple steps of the process, usually in stages and is used to determine if the project is meeting specification.The specifications of the project are highly detailed, and the project manager will evaluate the validation process to be sure the project is meeting the requirements. The validation helps advance the project and measures progress.The key benefit of this process is that it brings objectivity to the acceptance process and increases the chance of final product, service, or result acceptance by validating each deliverable. Design validation provides evidence beyond theoretical that the device you designed is truly safe and effective within the context of those same design input requirements.