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FDA medical device regulations graphs.

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

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.
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April 5, 2023

Sterling Medical Devices Creates Controller to Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

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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