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.

ISO-certified

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.

Resources

Hands compare spinal x-rays

January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...
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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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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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