Medical Device Consulting

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.

  • Complete Quality System development
  • Risk assessment & hazard analysis consulting
  • Part 11 & HIPAA Compliance review
  • Quality system review, then develop and implement a remediation plan, if applicable
  • FDA, ISO and CE medical device safety consulting
  • and much more…
 
Contact Us

Consult with Experienced Professionals

Sterling Medical Devices has developed more than 500 medical device products for over 125 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.

Resources

March 29, 2021

What Is Polarion?

Learn more about our tool that streamlines product development in a compliance-based...
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October 22, 2021

What Does it Mean to be ISO 13485 Certified?

Compliance with ISO 13485 and Quality System Regulation (QSR) ensure that your Quality Management System (QMS) is robust and meets the regulatory requirements on the international level. But beyond...
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April 28, 2021

Leading You Into the Next Era of Product Development

Do you waste time going back and forth with team members asking for status updates? Do you find yourself searching around for the most recent...
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    Dan Sterling Photo of Dan Sterling President
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 dan@sterlingmedicaldevices.com
    John Campbell Photo of John Campbell VP of Operations
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jc@sterlingplm.com
    John Fargo Photo of DanJohn Fargo PLM Manager
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jf@sterlingplm.com