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Wherever you are in your product development lifecycle,
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Device Classification

Classify Your Device Correctly

Getting the classification wrong can have serious consequences for your budget and timeline. It’s important to do your research and work with experts to ensure you’re selecting the right classification for your device. Don’t let incorrect product classification derail your development process and cost you valuable time and resources. Get it right the first time and save yourself the heartache of costly delays.

Sterling can help.

Let us help you get it right. Our team of experts can provide the guidance and support you need to classify your medical device correctly, so you can move ahead with confidence. Your classification will determine the regulatory strategy you need to follow to bring your device to market.

For a deeper look at the difference between a Class I and Class II medical devicehow to classify a Class III medical device, and other industry insight, please check out our blogs. Contact us today to learn more about how we can help. 

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About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 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 also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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Resources

selection agile development

November 12, 2021

Agile Development in a Medical Device Company Can Save Time and Money

“The Sterling Approach” to medical device design focuses on our customers’ experience -  a critical component is our Agile project management. Agile development in a medical device company is...
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5 Mistakes Medical Device Startups Make

February 18, 2021

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.
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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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