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Wherever you are in your product development lifecycle,
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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. 

Resources

Person using mobile medical device app

August 10, 2021

The Proliferation of Mobile Medical Devices—Revolutionizing Healthcare

Mobile devices are ubiquitous in today’s day and age; they’re everywhere—and for good reason: your smartphone is a hand-held computer allowing you to stay connected at all times. As a result,...
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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