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mb698 replied to the topic Design Validation in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
Design validation in medical devices is that it meets the user needs and intended uses. Design validation involves testing to demonstrate that he medical device functions as expected and meets the user needs. There could be incorporations of inspections and analyses as a part of validation in addition to the testing. Validation is important because the demonstrates that the device has met the user needs or not. Compromising on the validation would not execute the proper testing. Validation is important since the device meets the safety standards, characteristics and requirements.