Sterling Medical Devices participated in the development of a Class III device that helps an untrained civilian administer CPR to a patient in critical condition. Our team added a feedback mechanism to the device to address the FDA’s response to a previous 510k submission. The update involved a feasibility review, manufacturing assessment, and development of the feedback mechanism. We also heavily revised the existing DHF. The device system received 510k approval upon resubmission. Development was performed under Sterling’s QMS then transferred to the client’s QMS.