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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 Outsourcing

Medical Device Outsourcing

From design, to engineering, to testing, and beyond, Sterling Medical Devices will work with you at any phase of the process. Our diverse set of services and credentials will help your device to get to market faster.

  • Human Factor Analysis
  • Usability Testing
  • Evaluating and changing device design
  • Testing and validation to ensure optimization
  • Risk analysis, evaluation, and mitigations
  • ISO13485 registered, IEC 62304, ISO 14971 and IEC 60601-1 compliant
  • Has successfully guided over 400 client medical device projects through the FDA approval process

Outsource from Sterling’s group of highly-experienced, focused and flexible experts who will guide your medical device project through to completion the right way. Contact us to learn more about how we can perfect your medical device development process.

 
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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

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February 24, 2018

Gap Analysis

Bridging the Gap between Good to Even Greater All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality...
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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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September 26, 2022

Sterling Medical Devices Creates Controller to Power Puzzle Medical Devices Inc’s. Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Overview Puzzle Medical Devices Inc., is a leading medical device company specializing in the development of a minimally invasive multi-pump mechanical circulatory support (MCS) designed to reduce...
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