Sterling Medical Devices participated in the development of a Tongue Implant System. The system was composed of microprocessing devices, including a controller and an external mouthpiece, which act...
Sterling Medical Devices participated in the development of a Class III breathing pacemaker intended for use by patients who have lost neurological control of respiration. The pacemaker is now used...
Sterling Medical Devices participated in the development of a Class III hospital driver to support patients who’ve received an implanted heart until their condition becomes clinically stable....
New Proposed FDA Medical Device Quality System Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical...
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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