Medical Device Consulting

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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.

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Resources

July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...

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.

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!