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Regulatory Affairs



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Author: Lorena Mosquera | March 7, 2023

Regulatory Affairs

Meet regulatory requirements to develop and maintain a safe and effective deviceAt Sterling, we know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies...
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Author: Lorena Mosquera | November 8, 2022

Commonly Overlooked Cybersecurity Threats

You’re Not Thinking of Them but Hackers AreTechnology is ever-evolving, ever-advancing, and ever-changing. With all its positives, technology has also created challenges. They are even more...
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Author: Lorena Mosquera | October 20, 2022

FDA Form 483

As a medical device manufacturer, you are likely all too aware of the looming threat of that dreaded FDA Form 483. This letter indicates that an the investigator(s) has observed conditions that in...
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Author: Lorena Mosquera | October 20, 2022

FDA Warning Letter Support

Has your company received an FDA warning letter? The FDA will issue a warning letter notifying you if they find a violation or non-compliance regarding your device. These letters indicate serious...
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Author: Sterling Medical Devices | September 29, 2022

How Regulatory Changes Can Impact Product Development

How Regulatory Changes Can Impact Product Development: Insights from Global MedTech Regulatory Trends: True Quality Summit SeriesThe MedTech global regulatory landscape is evolving. What is the...
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Author: Sterling Medical Devices | May 4, 2022

CE-Post Market Surveillance

Stay compliant in any market. Unload the burden of post-market surveillance activities to the experts!We offer full-service Post-Market Surveillance (PMS) planning and execution for all markets, for...
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Author: Sterling Medical Devices | May 3, 2022

FDA Human Factors Documentation Support

Human factors engineering, or medical ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. The U.S. Food and Drug...
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Author: Sterling Medical Devices | May 2, 2022

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...
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Author: Sterling Medical Devices | May 2, 2022

CE Premarket Approval

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...
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Resources

quality systems regulations

November 17, 2021

Understand Quality Systems Regulations to Avoid FDA Enforcement Actions

Medical devices are regulated in the United States by the Food and Drug Administration (FDA) because of the great responsibility and risk they carry regarding human life. To be sold in the U.S., a...
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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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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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