FDA’s Design Control Requirements for Medical Devices

Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC

20160725

FDA reviews, evaluates, verifies and validates the implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, the manufacturing process to the finished device for user needs. Design controls are an integrated set of management practices and procedures which are applied to control design activities while assessing and maintaining device quality throughout the total product life cycle (TPLC).

Posted in White Paper.