Involvement in
over 1,100 projects

none of which failed to receive FDA
regulatory approval upon submission.

About Sterling Medical Devices

At Sterling, we address the whole development process – systems, software, electronics, mechanical, quality, and compliance – and design our clients’ products with a focus on the needs and requirements of the user, while also making smart design choices that are based on our extensive and diverse experience in product development.

Founded in 1998, Sterling Medical Devices, specializes in the product design and engineering of medical devices for the healthcare industry.  Dedicated to resolving our clients’ medical device design and engineering challenges, we address the whole development process, including product design and human factors, systems, software, electronics, mechanical, quality and compliance.  We utilize the latest tools and technology to streamline the engineering process to speed regulatory approval of Class I, II and III devices.  To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients.

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Resources

Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

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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Person working on medical device

October 29, 2020

Sterling Medical Devices Unveils Innovation Growth

MOONACHIE, NJ — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, is pleased to announce the renovation of their Regulatory Affairs Department that will now focus on providing strategic guidance and collaboration...
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design-medical-device-sharpdesign-medical-device-sharp

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers,...

September 11, 2020

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