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Heart monitor system

Bench-Top Device Cart-Based/Table Top Desktop Device Electro-Mechanical

Defibrillator IDE

Sterling Medical Devices aided in the creation of an Integrated Development Environment (IDE) for the generation of defibrillator software and firmware development. First, Sterling developed a State...
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Blood Sample Diagnostic Analyzer

Bench-Top Device Cart-Based/Table Top Electro-Mechanical

Genetic Analyzer

Sterling Medical Devices wrote documentation and performed software development for a prognostic genetic analyzer....
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Blood Analyzer Software

Bench-Top Device Cart-Based/Table Top Electro-Mechanical

Blood Sample Analyzer System

Sterling Medical Devices participated in the development of a Class II blood analyzer system with Moderate Level-of-Concern software....
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Bench-Top Device Cart-Based/Table Top Electro-Mechanical

EEG Capture and Display System

Sterling Medical Devices participated in the development of EEG Capture and Display systems....
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Heart sound analysis system Heart sound analysis system

Bench-Top Device Cart-Based/Table Top Electro-Mechanical

Heart Sound Analysis System

This device was developed to collect acoustic data of the heart function and analyze the data to generate readings including heart rate....
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Heart monitor system

Bench-Top Device Cart-Based/Table Top Electro-Mechanical

Heart Monitor System

This project focused on the development, testing, and refinement of the software and hardware for a heart monitor system....
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Resources

Medical professional pointing at FDA icon.

November 3, 2023

An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

In September 2023, the FDA Office of Combination Products (OCP) released the Application of Human Factors Engineering Principles for Combination Products, a finalized version of the February...
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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