Medical Device Projects

At Sterling Medical Devices, we provide a wide range of medical device services to help take your ideas for medical device projects from concept to market. Below are some of our past medical device projects to illustrate the scope of work we can provide while respecting the privacy and confidentiality of our clients. If you are looking for more in-depth examples of our design and development work, please review our case studies.



CPR System

Development

CPR Assistance System

Sterling Medical Devices participated in the development of a Class III CPR assistance system that helps an untrained civilian administer CPR to the patient in critical condition. To address the...
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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. The diagnostic system is composed of an embedded device coupled...
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Quality System

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

EEG Capture and Display System

Sterling Medical Devices participated in the development of Electroencephalography (EEG) Capture and Display system. EEG capture uses external electrodes placed on the scalp to capture electrical...
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Artificial Hearts

Electro-Mechanical Implantable Implanted Devices

Artificial Hearts

Sterling Medical Devices participated in the development of a Class III hospital driver to support patients who’ve received an implanted heart until their condition becomes clinically stable. The...
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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

The heart sound analysis system collects acoustic data of the heart function and analyzes the data to generate readings including heart rate. It also indicates when certain indicators of heart...
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Heart monitor system

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

Heart Monitor System

The heart monitor system connects to a non-invasive sensor to upload EKG readings on a regular basis, displays current values, and charts the data. It monitors readings to alarm when the readings are...
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Glucose strip meter system Glucose strip meter system

Development Hardware Software Testing

Glucose Strip Meter System

The glucose strip meter system reads strips and calculates glucose readings.  The system displays current values and charts the data, and monitors readings to alarm when the readings are above or...
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Handheld Device Hardware Software

Continuous Glucose Monitor System

The glucose monitor system connects to a non-invasive sensor to upload glucose readings on a regular basis. It displays current values, charts the data, and monitors readings to alarm when the...
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Active Drug Delivery System

Cart-Based/Table Top Electro-Mechanical

Active Drug Delivery System

The active drug delivery system consists of a couple of different wearable instruments providing drug delivery; one via a complete mechanical solution and another via an electromechanical solution....
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Resources

FDA medical device regulations graphs.

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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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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