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mb698 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
Design validation proves that the medical device meets the user needs and intended uses. It assures that the product meets the needs of the customers. It is important to do the design validation earlier in the project because it determines if it effectively demonstrated the medical device meets the user needs. Validation is important in the design, development and production of medical devices. Effective and appropriate validation plays an important role in defining the success of a product. Design validation is important because it provides theoretical assurance that the design is appropriate in regard to the defined design input requirement, is safe and effective.