Thought Leadership

Author: Carrie Britton | September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...

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...

A woman works on a plan for medical device startup companies

Author: Erik Hilliard | August 11, 2021

5 Mistakes Medical Device Startup Companies Make

Medical device startup companies play an integral role in the medical device industry. They have the ability to be nimble and take more risks on a unique product that larger, more established...

Author: Erik Hilliard | August 10, 2021

The Proliferation of Mobile Medical Devices—Revolutionizing Healthcare

Mobile devices are ubiquitous in today’s day and age; they’re everywhere—and for good reason: your smartphone is a hand-held computer allowing you to stay connected at all times. As a result,...

fda real world evidence on mobile device

Author: Carrie Britton | July 28, 2021

FDA’s Real-World Evidence Program – Summary of Patient Data Assessment Report

The FDA is responsible for ensuring the safety and effectiveness of regulated medical devices and assuring that patients have timely access to the devices while advancing innovation. It is a...

technician manufacturing medical devices

Author: John Campbell | July 21, 2021

Good Manufacturing Practices for Medical Devices: Risk Management

The clients we work with at Sterling Medical Devices often know they want to produce a high-quality medical device, but unfortunately too often do not fully understand an element essential to good...

Man performs verification and validation testing

Author: John Campbell | 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...

Tablet displays an x-ray of a person, demonstrating medtech and the internet of medical things

Author: Keith Handler | June 13, 2021

Internet of Things (IoT) for Medical Devices—How It’s Changing Healthcare

As we continue to see barriers to healthcare access, particularly during the COVID pandemic, we’ve also seen a rapid expansion of IoT (Internet of Things) in medicine. A system of wireless,...

Author: Carrie Britton | May 24, 2021

How to Prepare for an FDA Inspection

As a medical device manufacturer, you are likely all too aware of the looming threat of an FDA inspection of your quality systems and risk management protocols. While the FDA approval process has...

Resources

Healthcare professional developing a medical device concept

December 5, 2022

Medical Device Concept Development: Important Factors to Understand

Medical Device Concept Development: Important Factors to Understand Designing, developing, and bringing to market a new medical device is a complex enterprise. Each step is a learning process...

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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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Thought Leadership

How Long Does it Take the FDA to Approve a Medical Device?

FDA’s Software Precertification Program

5 Mistakes Medical Device Startup Companies Make

The Proliferation of Mobile Medical Devices—Revolutionizing Healthcare

FDA’s Real-World Evidence Program – Summary of Patient Data Assessment Report

Good Manufacturing Practices for Medical Devices: Risk Management

Do you know the difference between verification and validation?

Internet of Things (IoT) for Medical Devices—How It’s Changing Healthcare

How to Prepare for an FDA Inspection

Resources

Medical Device Concept Development: Important Factors to Understand

5 Mistakes Medical Device Startups Make

Scalp Cooling System

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