Medical Device Design Industry Blog

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The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.

fda real world evidence on mobile device

Author: Carrie Hetrick | 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 Hetrick | 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...

difference between project management systems

Author: Sterling Medical Devices | May 3, 2021

What’s the Difference Between ALM and PLM?

The terms Application Lifecycle Management (ALM) and Product Lifecycle Management (PLM) are frequently used interchangeably. And while the two are often intertwined, they are not the same thing....

Author: John Campbell | April 27, 2021

Smart, Cost-effective Medical Device Testing

Your medical device is designed to help patients improve their quality of life—from treating minor illnesses to saving lives. The sooner you get your device on the market, the better for everybody....

Author: Carrie Hetrick | April 15, 2021

How to Classify a Class III Medical Device

Last month, we began our series examining the classification of medical devices, with a deep dive on the differences between a class I and class II medical device. Today, we will explore the topic...

Author: Carrie Hetrick | April 8, 2021

What’s the Difference Between a Class I and Class II Medical Device?

One of the most common questions when it comes to medical device regulation is, “What is the difference between a class I and class II medical device?” Today, we will explore the topic in more...

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United States of America and Medicine button on keyboard

March 17, 2022

What Country Leads the World in Medical Innovation

We’ll get right to the point. The answer to the question, “what country leads the world in medical innovation?” is the United States. Medical industry professionals all over the world...

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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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November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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