Kaiser Aziz Archives - EAS Consulting Group

FDA’s Design Control Requirements for Medical Devices

Aug 1, 2016 | Issue of the Month, Medical Devices

By Kaiser Aziz, PhD., EAS Senior Consultant FDA reviewers and field investigators evaluate design control requirements and processes for medical devices and make recommendations based on whether the manufacturer has the required checks and balances in place. Design...

FDA’s Design Control Requirements for Medical Devices

Jun 25, 2016 | Medical Devices, White Paper

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 …