Device Classification

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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 device, how 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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February 9, 2023

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