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. 

Resources

doctor pointing to screen with icons

April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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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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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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FDA/CE approval with a free custom project analysis.
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