International Regulatory

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

Computer screen of a medical device

September 20, 2021

Ways to Improve Medical Device UX Through Better Design

When it comes to the design and development of medical devices, ensuring a positive user experience (UX) is not a nice-to-have; it’s essential. As users’ needs expand and more connected...
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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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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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