Sterling aided in the verification to an update of an imaging system. This system is Class II device with a Moderate Level of Concern. The verification protocols covers the desktop application, CCU...
Sterling Medical Devices participated in the development of an image-guided surgery system including optical tracking devices and localization probes. The system helps surgeons obtain an accurate...
Sterling Medical Devices helped redevelop a remote support web application software targeted to address the underlying cause of tinnitus. The original system was written in Flex. The system has a...
Sterling Medical Devices participated in the development of 3D motion characterization turnkey software to record magnetic field data. This customized software tested the capabilities of an implanted...
Sterling Medical Devices participated in the development of a proof-of-concept gynecological scope prototype. During phase 1, Sterling authored a project plan and requirements documentation designed...
Sterling Medical Devices participated in the investigation and remediation of five medical devices with CAPA issues, all made by the same company. In general, CAPA (Corrective and Preventive Action)...
On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...
Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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