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pi29 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
The purpose of the design validation is to confirm that the product’s intended use is what it’s designed to be. Not just the product, but whatever the project is. For example, during my internship there was a project that needed validation of the packaging. The purpose was to make sure that the packaging process did not introduce for example pinholes or tears to the packaging, or damage to the seals, as well as that the final package retained its integrity after x amount of time at the storage temperature. The validation had passing results at the end of the study however in other cases sometimes red flags are raised that alerts the quality team to possible concerns in the future. It’s an important process that helps confirm the intended use of the material/s being tested and determine possible product concerns that could affect for example product shelf life.