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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…
 
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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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Professional on computer reviewing ISO documents.

October 18, 2023

What’s New in ISO 10993-17:2023?

In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...
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April 19, 2023

Requirements Management and Cybersecurity Webinar

Do you struggle with managing requirements for your products? Are you concerned about cybersecurity and the potential impact of software...
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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