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Medical Device Cybersecurity

Applications Desktop Application Electro-Mechanical Handheld Device Mobile Application Web Application

Glucose Diary Software System

Sterling developed a glucose diary software system which consists of glucometer hardware, glucose diary software, and PC and Smartphone hardware....
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Applications Desktop Application Web Application

Image Processing Connections System

Sterling Medical Devices assisted in the iterative development of a Major Level of Concern connection system between a series of video processors and a third party computer system. The system was...
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Image Processing Connections System

Applications Desktop Application Desktop Device Web Application

Dental Imaging System

Sterling Medical Devices participated in the development of a Class I intraoral dental imaging system. The system uses an HD camera to provide real-time picture and video for diagnosis and patient...
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Orthopedic Imaging System

Applications Desktop Application Web Application

Orthopedic Imaging System

Sterling Medical Devices performed development on a Class II orthopedic imaging system with Moderate Level of Concern software. Our client had acquired an unfinished software application, which we...
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Gynecological Scope

Applications Desktop Application Desktop Device Preoperative Planning Tools Web Application

Preoperative Planning Tools

Sterling Medical Devices planned and managed development of Class II preoperative planning software for orthopedic surgeons. The moderate level of concern software was developed in C, C++, and...
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Resources

Medical professional on the computer analyzing medical device software.

July 14, 2023

Insight on Updated FDA Device Software Guidance

The US Food and Drug Administration (FDA) recently issued a new guidance document: Content of Premarket Submission for Device Software Functions. The revamp of the FDA’s software guidance for...
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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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