FDA design control is defined as an interrelated set of quality practices and processes for medical devices design and manufacturing. Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design controls make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. Design controls intend to increase the chances of transferring the design to production, without much difference, into a device suited for its intended use.
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