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...
Understanding Form FDA 483 Observations The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu...
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.
Controller to Power Groundbreaking New Multi-Pump Mechanical Circulatory Support Device Medical Device Need A controller for an implantable heart pump that...
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