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 3D motion characterization turnkey software to record magnetic field data. This customized software tested the capabilities of an implanted...
Sterling developed and updated software for a large pharmacy pill dispenser to run diagnostics and system maintenance. Pill dispensers are used to dispense pills and liquids for commonly used medical...
Sterling Medical Devices participated in the development of a patient monitor system with Moderate Level of Concern software in order to support a 510(K) submission. Sterling performed document...
Sterling Medical Devices participated in the development of a powered knee system. The powered knee system serves as a prosthetic limb that is highly adaptable to various movements, thanks to data...
"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device...
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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