Why Sterling

At Sterling Medical Devices, we’ve been delivering medical device design innovation—from concept to market—for more than two decades, earning us the reputation as the best medical device consulting company on the market today.

What Sets Us Apart?

Faster time-to-market

We’ll incorporate the most current guidelines and regulations, best practices, and the latest tools in the industry to bring a superior product to market, quickly and cost-effectively. With vast experience, backed by proven quality systems, we know how to avoid the costly delays associated with the typical project—from innovation and development through testing, release, and beyond.

Unparalleled medical device innovations

Widely known as the best medical device consulting firm around, we take a customized, out-of-the-box approach to meeting your unique needs. With access to deep experience from our seasoned team of experts, you don’t just get a quality product with fast regulatory approvals—you get superior medical device design innovation, from concept to market.


We are ISO 13485-registered, the industry’s most widely used international standard for quality management. We know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies worldwide—which translates to guaranteed quality assurance of your medical device. 

In-house team of U.S.-based experts

Our team is comprised of the best medical device consultants in the industry, each of whom brings extensive experience in medical device design and development. We are 100% U.S.-based, and we’ve successfully completed hundreds of medical device projects like yours. This translates to a faster, more cost-effective market entry of your device.

Ongoing collaboration

At Sterling, you are part of the process. We’ll listen to you, understand your challenges, and partner with you to deliver medical device innovations for a quality product with quick regulatory approval. Whether serving as your full-time development team or aiding your existing team with a specific need, we will keep you well informed and involved throughout the entire process.



September 11, 2020

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, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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Potential Coronavirus Treatment

April 29, 2020

Sterling Medical Devices Partners with Cedars-Sinai and Aytu BioScience on Potential Coronavirus Treatment

MOONACHIE, NJ, April 29, 2020 — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, announced today their partnership with...
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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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