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.

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. 

Need help with your medical device?

Let Vantage MedTech show how to bring your idea from concept to prototype to FDA/CE approval with a free custom project analysis.