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  • sns34 replied to the topic Discussion Topic: Verification vs. Validation in the forum The Design History File 8 years, 2 months ago

    Although it is easy to mix up the concepts behind design verification and design validation, both of them consist of different aspects that ultimately combine to form part of the Design Control. Design Verification confirms that the design output meets the design input requirements. Thus, it confirms that the design meets the product specifications and it performs as it should. It involves tests, inspections, and analysis of the product. Design Validation ensures that the device meets customer needs and intended uses.
    Design and Process V&V go hand-in-hand and are also set apart in different ways. At the end of the entire process of producing a medical device, the validation of both the design and the process overlap and must be the same. The end goal is to create a product that is completely functional and meets customer needs. On the other hand, design and process verification is separate because it makes sure that the SOP is followed. The material to create the product and the equipment used to test the product must be taken into account. It is all part of a dry run of the verification process.