The purpose of the design control subsystem is to control the design process to assure that devices meet user needs, intended uses, and specified requirements. Determine if the design was correctly transferred.Determine if design reviews were conducted.Confirm that changes were controlled including validation or where appropriate verification.Determine if design validation was accomplished using initial production devices or their equivalents. Confirm that risk analysis was performed.If the device contains software, confirm that the software was validated.Confirm that the completed design validation did not leave any unresolved discrepancies.Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.Determine if design verification confirmed that design outputs met the design input requirements.
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