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Medical Device Design and Development Services


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


Physician organizing single use surgical masks.

March 14, 2022

What are Disposable Medical Devices and Why Are They Important?

There is an increased demand in reusable materials in order to reduce waste, but when device companies can create disposable medical devices, it increases patient safety and reduces risk....
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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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April 5, 2023

Sterling Medical Devices Creates Controller to Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Controller to Power Groundbreaking New Multi-Pump Mechanical Circulatory Support Device Medical Device Need A controller for an implantable heart pump that...
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