Pre-Market Clearance and Approval

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Accelerate Your Product’s Time-To-Market With Our Experts!

The submission process is a tedious and lengthy endeavor. It is critical to understand the FDA’s expectations for a premarket submission. Beyond the list of requirements, a deep understanding of the details is the key to preventing potential headaches down the road. A complete submission can drastically reduce time to market clearance. Fortunately for you, that’s where Sterling steps in! Our team of experts has decades of regulatory experience. We will handle the entire process so there are no hiccups or delays along the way.

Our team can support your:

FDA 513(g) Request for Information
FDA Q-Submission
FDA 510(k)
FDA Investigational Device Exemption (IDE)
FDA De Novo Petition
FDA HUD and Humanitarian Device Exemption (HDE)
Emergency Use Authorizations (EUA)
Premarket Approval (PMA)

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Sterling can help.

We have a deep understanding of the many ins and outs of the FDA requirements, so you can leave all the details to us. We will manage the entire process, start to finish. Let us help get your device to market! Contact us today.

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

May 16, 2023

Who Needs a Q-Sub, and When?

So many questions come up when developing a medical device. What is its intended purpose? Who will use it? How will it be used? What do we need to do? Questions surrounding the medical device...

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.

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....

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

Just fill out this form and we’ll be in touch!