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Author: Sterling Medical Devices | May 4, 2022

CE-Post Market Surveillance

EU MDR/IVDR Post-market SupportBefore bringing your device to market, you went through a series of rigorous regulatory processes to get it approved for commercialization. But because some risks...
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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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Author: Sterling Medical Devices | April 28, 2022

QMS Design, Implementation, & Training

Production without a stringent Quality Management System (QMS) may adversely affect the reputation of a company, whether that means decreased consumer confidence, compliance issues, corrective...
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Author: Sterling Medical Devices | April 26, 2022

Medical Device Quality Systems

Searching out improvements in quality, though valued, is often neglected during the development process due to weak quality controls. A focus on production without a stringent Quality Management...
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Author: Sterling Medical Devices | April 26, 2022

Pre-Market Clearance and Approval

Selecting and preparing the correct premarket submission for your medical device is crucial, saving you time, money, and headaches in the process of getting your product to market. Clearance and...
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Author: Sterling Medical Devices | April 25, 2022

QMS Compliance and Remediation

Sterling has decades of experience helping clients achieve and maintain regulatory compliance.As a medical device manufacturer, you are likely all too aware of the looming threat of nonconformance...
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Resources

Man performs verification and validation testing

July 7, 2021

Do you know the difference between verification and validation?

Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? Verification...
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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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July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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