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FDA 510(k)-Clearance-Approval

Author: Carrie Britton | January 10, 2022

The COVID-19 Pandemic and 510(k) Clearances

The global COVID-19 pandemic, and the subsequent public health emergency it created, changed much about our everyday lives, and the medical device industry is no exception. To respond quickly to...
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Doctor on tablet considering medical device artificial intelligence

Author: Carrie Britton | December 20, 2021

The Use of Artificial Intelligence in Medical Devices

Artificial intelligence (AI) is a powerful and ever-emerging technology that has the potential to improve capabilities across a multitude of industries. Medical devices with artificial intelligence...
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Medical Device Cybersecurity

Author: Keith Handler | December 20, 2021

Why Medical Device Cybersecurity Matters

In our post-pandemic, socially distant world, tech-enabled distributed healthcare has become ubiquitous. As medical devices get more advanced to support this evolving landscape, so do the...
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Doctor examining medical device report

Author: Carrie Britton | December 20, 2021

A Guide to FDA Design Controls for your Medical Device

Medical devices hold great responsibility and risk – if they aren’t working properly, there could be dire consequences for a person’s health and potentially life. Because of this, they are...
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medical device approval process

Author: John Campbell | November 17, 2021

Strategies for Navigating Medical Device FDA and CE Approval

At Sterling, some of the most common questions we get are related to medical device Food and Drug Administration (FDA) approval in the U.S. and the Conformite Europeenne (CE) mark in the European...
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selection agile development

Author: Jamme Tan | November 12, 2021

Agile Development in a Medical Device Company Can Save Time and Money

“The Sterling Approach” to medical device design focuses on our customers’ experience -  a critical component is our Agile project management. Agile development in a medical device company is...
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Author: Carrie Britton | August 26, 2021

FDA’s Software Precertification Program

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a...
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Resources

circuit board graphic

July 16, 2019

A New Era of Cybersecurity

Cybersecurity has become a major concern over the years as technology has advanced. Device manufacturers are searching for ways to keep security up to date with the demand for stricter scrutiny for...
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View More Blogs

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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