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Project Management Software Development Testing Validation

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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Glucose strip meter system Glucose strip meter system

Development Hardware Software Testing

Glucose Strip Meter System

Sterling developed a glucose strip meter system that reads strips, calculates glucose readings, displays current values, and charts the data....
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Continua Based System

FDA Validation Testing For Medical Devices Software Testing

Continua Based System

Sterling developed interfaces for a client’s healthcare products based on Continua, a system of interoperable, personal connected health solutions....
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Resources

Professional calculating medical device finances.

August 22, 2023

FDA Medical Device User Fees (MDUFA) for 2024

On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...
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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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