Thought Leadership



medical device approval process

Author: John Campbell | November 17, 2021

Strategies for Navigating Medical Device FDA and CE Approval

At Sterling, some of the most common questions we get are related to medical device Food and Drug Administration (FDA) approval in the U.S. and the Conformite Europeenne (CE) mark in the European...
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quality systems regulations

Author: Christine Scheve | November 17, 2021

Understand Quality Systems Regulations to Avoid FDA Enforcement Actions

Medical devices are regulated in the United States by the Food and Drug Administration (FDA) because of the great responsibility and risk they carry regarding human life. To be sold in the U.S., a...
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applying human factors and usability engineering to medical devices

Author: Tara Miller | November 16, 2021

Applying human factors and usability engineering to medical devices

Human factors (HF) and usability engineering (UE), or as some call it, medical ergonomics, is the process of evaluating and changing the design of a device to better fit the human body and its...
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selection agile development

Author: Jamme Tan | November 12, 2021

Agile Development in a Medical Device Company Can Save Time and Money

“The Sterling Approach” to medical device design focuses on our customers’ experience -  a critical component is our Agile project management. Agile development in a medical device company is...
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medical device regulation compliance

Author: Christine Scheve | October 22, 2021

Common Medical Device Regulatory Compliance Roadblocks

The medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and...
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Computer screen of a medical device

Author: Anthony Caivano | September 20, 2021

Ways to Improve Medical Device UX Through Better Design

When it comes to the design and development of medical devices, ensuring a positive user experience (UX) is not a nice-to-have; it’s essential. As users’ needs expand and more connected...
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person holding a circuitboard

Author: Larry Bischoff | September 10, 2021

Types of Medical Device Patents: What You Need to Know

In recent years, we’ve seen more innovation in medical devices, particularly with the proliferation of mobile medical devices—a trend that exploded further due to the COVID pandemic. With...
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Author: Carrie Hetrick | 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...
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Author: Carrie Hetrick | 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...
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Resources

difference between project management systems

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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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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people developing a product

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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