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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

Doctors hands showed FDA approval sign

February 9, 2023

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Are you a medical device developer with questions about when and how to file for regulatory approval? Navigating the complexities of the FDA premarket approval process can be daunting. But it...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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