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Wherever you are in your product development lifecycle,
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Medical Device Design and Development Services – Copy


At Sterling Medical Devices, we help clients resolve medical device design and development challenges—from concept through completion. With more than two decades of experience delivering unparalleled medical device innovation and a customized, out-of-the-box approach to meeting clients’ unique needs, our U.S.-based team of experts is known for helping manufacturers bring a superior product to market, quickly and cost-effectively. As an ISO 13485-certified partner, we know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies worldwide—which means guaranteed quality assurance for your product. When you work with us, you get a collaborative partner with advanced expertise across the entire product development lifecycle. 

Who is Sterling Medical Devices?

At Sterling, we are dedicated to the customer experience and ensuring that our clients receive the attention they deserve and the communication they expect. Our team focuses on our clients and their projects to help them on the path to success.

Why Sterling Medical Devices?

  • Faster time-to-market
  • In-house team of U.S. based experts
  • Unparalleled medical device innovations
  • On-going collaboration with our clients
  • ISO-certified


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Smart, Cost-effective Medical Device Testing

Your medical device is designed to help patients improve their quality of life—from treating minor illnesses to saving lives. The sooner you get your device on the market, the better for everybody....
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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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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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Need help with your medical device?

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