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...
If you're developing a medical device, you've probably heard of the FDA's De Novo classification process. You may be wondering if it's the right regulatory pathway for your device. In this blog...
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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