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

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Medical Device Consulting

Whether Electro-Mechanical, Software, or Wearable/Internet of Things (IOT) –

Consulting Saves Time & Money

Partner with a highly-experienced, focused, and flexible group of experts who will help see your medical device project through to completion the right way.

  • Quality Management System Compliance Review and Development
  • Risk Assessment, Hazard Analysis, FMEA Consulting
  • Cybersecurity Analysis and Remediation
  • 21 CFR 820, ISO 13485, ISO 60601, IEC 62304, Part 11 & HIPAA Compliance Review
  • FDA, ISO and CE Compliance Consulting
  • and much more…

 

Consult with Experienced Professionals

Sterling Medical Devices has developed more than 1000 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 have also partnered with a number of early-stage companies to help them bring new products to market.

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At Any Stage…

Sterling is ready to work with you at any stage of your development lifecycle.  From startups to mature companies, we have experience solving tough problems in a timely manner. 

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Resources

FDA medical device regulations graphs.

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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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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