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Medical Device Design Industry Blog



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.


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...
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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...
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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,...
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FDA-inspection-process

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...
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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....
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hand tests medical device

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....
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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...
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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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Author: Carrie Hetrick | February 18, 2021

The New EU Medical Device Software Requirements

With the EU’s new medical device software (MDSW) requirements, the guidance related to qualification, classification, clinical evaluation and cybersecurity present challenges for software as a...
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Resources

February 1, 2022

Minimally Invasive Devices

An Overview of Minimally Invasive Devices Minimally invasive devices have revolutionized the medical device industry. Using minimally invasive technology has improved patient outcomes and...
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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