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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November 13, 2024

Vantage ALM announces new branding as Vantage ALM

MOONACHE, N.J. and LENEXA, Kan., November 13, 2024 – Vantage ALM, a Vantage MedTech Company has announced it is rebranding as Vantage ALM. Vantage ALM helps engineering companies across the globe...
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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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