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Interested in learning more about how we can work together in your current or next medical device design project?

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Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

Medical Device Engineering

Medical Device Engineering

Whether you are seeking to design a new medical device product or improve an existing device, Sterling’s unique approach to the device engineering process can help.

  • Design for implantable devices, external support and monitoring devices, mobile app medical devices, 510K, PMA and CE class I, II, III device
  • Critical chain model with a built-in safety buffer for accurate timeline estimates and transparency
  • Reverse engineering service allows customers to create prototypes and utilizes prior work for documentation for regulatory approval
  • Sterling’s ISO certifications speed up start-up customers’ regulatory approval processes

From small startups, to leading medical device organizations, we have helped several companies bring their medical devices to the market faster while ensuring that the development process is carried out without fault. Contact us to learn more about how we can accelerate and perfect the engineering process for your medical device.

 
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About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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Resources

Nick Testing Web

February 7, 2018

Hazard Analysis

What is a Hazard Analysis for a Medical Device? Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. The steps in conducting a hazard analysis entail identifying...
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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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