Thought Leadership

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 Britton | 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 Britton | 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...

Author: Carrie Britton | 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...

Author: Tara Miller | January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...

Hand,Of,Woman,Using,Mobile,Phone.she,Is,Deciding,To,Make

Author: Carrie Britton | September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....

Author: Dan Sterling | April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...

person typing on a keyboard with security graphics overlay

Author: Keith Handler | July 23, 2019

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical...

Resources

February 7, 2019

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What Does it Mean for the Medical Device Industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for...

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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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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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Thought Leadership

What’s the Difference Between ALM and PLM?

Smart, Cost-effective Medical Device Testing

How to Classify a Class III Medical Device

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

The New EU Medical Device Software Requirements

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Device Manufacturers Face Challenges to Balance Opportunity and Risk

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Resources

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

5 Mistakes Medical Device Startups Make

Implanted Drug Delivery System

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