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

August 8, 2022

Medical Device Supply Chain

Medical Device Supply Chain Challenges and FDA Action Supply chain delays and disruptions can wreak havoc on any business, especially in the highly regulated medical device industry....

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.

Sterling Medical Devices Creates Controller to Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Controller to Power Groundbreaking New Multi-Pump Mechanical Circulatory Support Device Medical Device Need A controller for an implantable heart pump that...

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

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