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Patient Monitor System

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...
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Resources

April 8, 2021

What’s the Difference Between a Class I and Class II Medical Device?

One of the most common questions when it comes to medical device regulation is, “What is the difference between a class I and class II medical device?” Today, we will explore the topic in more...
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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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September 26, 2022

Sterling Medical Devices Creates Controller to Power Puzzle Medical Devices Inc’s. Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Overview Puzzle Medical Devices Inc., is a leading medical device company specializing in the development of a minimally invasive multi-pump mechanical circulatory support (MCS) designed to reduce...
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