Thought Leadership

Physician’s hand holding FDA approval sign

Author: Indre Larson | March 14, 2022

What is FDA Premarket Approval?

At Sterling, we have helped bring hundreds of medical devices to market. While the products vary, the questions posed by the companies developing them are often the same. They want to know what it...

Physician organizing single use surgical masks.

Author: Bruce Swope | March 14, 2022

What are Disposable Medical Devices and Why Are They Important?

There is an increased demand in reusable materials in order to reduce waste, but when device companies can create disposable medical devices, it increases patient safety and reduces risk....

Doctor showing x-ray to patient on tablet

Author: Bruce Swope | February 14, 2022

What are Implantable Medical Devices?

According to an August 2022 report by The Global Implantable Medical Devices Market, the implantable medical devices market is projected to reach $157.07 billion by 2028.This boom is attributed to...

Letters GLP, representing Good Laboratory Practice

Author: Carrie Britton | February 14, 2022

Preparing for GLP Guideline Regulations in Medical Device Development

Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must...

Author: Carrie Britton | 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...

Author: Jeff Triolo | January 26, 2022

The role of 3D Printing in the Medical Device Industry

3D printing is a family of processes that creates three-dimensional solid objects from a digital file using computer-aided design (CAD). Also known as additive manufacturing, 3D printing offers...

Notes reading FDA recall signify the consequences of medical device failure

Author: Carrie Britton | January 26, 2022

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm By manufacturing and providing a medical device, you are taking on a big responsibility....

Author: Carrie Britton | January 10, 2022

The COVID-19 Pandemic and 510(k) Clearances

The global COVID-19 pandemic, and the subsequent public health emergency it created, changed much about our everyday lives, and the medical device industry is no exception. To respond quickly to...

Doctor on tablet considering medical device artificial intelligence

Author: Carrie Britton | December 20, 2021

The Use of Artificial Intelligence in Medical Devices

Artificial intelligence (AI) is a powerful and ever-emerging technology that has the potential to improve capabilities across a multitude of industries. Medical devices with artificial intelligence...

Resources

September 23, 2015

When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change...

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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

What is FDA Premarket Approval?

What are Disposable Medical Devices and Why Are They Important?

What are Implantable Medical Devices?

Preparing for GLP Guideline Regulations in Medical Device Development

Minimally Invasive Devices

The role of 3D Printing in the Medical Device Industry

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm

The COVID-19 Pandemic and 510(k) Clearances

The Use of Artificial Intelligence in Medical Devices

Resources

When Medical Device Software Fails Due to Improper Verification and Validation

5 Mistakes Medical Device Startups Make

Scalp Cooling System

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