Its very important on the validation process to make sure that the output equal to the user needs!. Before your company start marketing for a medical device, a successful validation should be submitted to the FDA according to FDA 21 CFR part 820. For a successful validation you need to answer some question like:
– Does the device work for the user?
– Does it meet the specified user needs?
– Does the device work in the user’s environment?
– Is the device’s usability easy, clear, obvious, and evident?
– Is the device safe and effective for both the user and the patient?
– Is the device meet user satisfaction and acceptability ?
So, I think every employee should know the answer for those questions to reach a successful validation.