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ajm73 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
Design validation is important in Project Management because it basically answers the question “Does this device do what it is supposed to do?”. If after testing is done the device is found to not perform at the requested level or even misses requirements, then the device is considered to have failed to met the design requirements. This is critical as the whole point of managing the project/device is to deliver on the initial requirements outlined in the beginning. If design validation is not done or is ignored, it can prove to be harmful to the end user and device maker. For the end user, the device may be used with a certain expected intention, but because it did not fulfill the needs, it can cause unexpected and/or harmful results. For the device maker because such a mistake is an expensive problem to fix and can cause harm to the maker’s reputation.