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Wherever you are in your product development lifecycle,
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Regulatory Strategy Support

Defining Your Regulatory Strategy Is Key

Our team has decades of experience helping medical device companies make sense of global regulatory landscapes in countries and regions all over the world. Whether it is in the US, EU, Canada, or elsewhere, we take the guesswork out of deciding which approval pathway is best for your device.

A regulatory strategy will include the interpretation of the country-specific regulatory requirements including:

  • Product code and regulation number determination
  • Classification determination
  • Identification of applicable standards and guidance documents
  • Confirmation or identification of potential predicate devices
  • List of applicable tests
  • Premarket pathway strategy
  • Quality system requirements
  • Claims and labeling review or guidance.
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Sterling can help.

A regulatory strategy is the first step in the long journey of bringing your device to market. We’ll help you navigate the complex regulatory maze and bring your medical device to market quickly and cost-effectively. Contact us now!   Let our experts guide you through this important process, every step of the way. 

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

Medical professional pointing at FDA icon.

November 3, 2023

An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

In September 2023, the FDA Office of Combination Products (OCP) released the Application of Human Factors Engineering Principles for Combination Products, a finalized version of the February...
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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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View More Videos
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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View More Case Studies

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