International Regulatory

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You want to get your product to market as quickly as possible, but to do so, you need to ensure you are complying with the strict regulations mandated across the medical device industry. Failing to do so can put your business—and more importantly, your end-users—at risk. Navigating the murky waters of international regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers.

Sterling can help.

Before bringing a medical device to market anywhere in the world, it is essential to determine the applicable regulatory requirements it must adhere to in order to ensure patient and user safety. With Sterling’s regulatory strategy support, we offer services to help you identify and address key international requirements for your device including:

Country-specific submissions in emerging countries
Health Canada license support
Health Canada submission
Outside U.S. and EU regulatory strategy

At Sterling, we can help you navigate the legal requirements for marketing your product around the world. When it comes to the increasingly complex world of regulatory submissions, we’ve got you covered.

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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

July 27, 2022

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

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