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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.


Doctor examining patient monitoring system

Author: Larry Bischoff | March 16, 2022

The Components of Patient Monitoring Systems

The medical device industry continues to pioneer and improve patient outcomes all over the world. One area of growth centers on patient monitoring systems. Remote patient monitoring systems...
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Safety Icons on Blocks

Author: Indre Larson & Jeni Leberknight | March 16, 2022

Medical Device Safety Standards

Approaching Medical Device Safety Standards Compliance In the United States, medical device companies that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. are...
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Physician working on tablet in hospital room

Author: Keith Handler | March 15, 2022

Recent Advances in Medical Technology

The impact of the COVID-19 global pandemic will be evaluated, studied, and felt for years to come, especially in the medical device industry. To protect public health, health care providers...
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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...
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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....
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Doctor showing x-ray to patient on tablet

Author: Bruce Swope | February 14, 2022

What are Implantable Medical Devices?

According to a November 2022 report by MarketWatch, the implantable medical devices market is projected to reach $638.5 million by 2028.This boom is attributed to several factors. As with most...
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Letters GLP, representing Good Laboratory Practice

Author: Carrie Hetrick | 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...
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Author: Carrie Hetrick | 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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3d printing of a medical device

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...
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Resources

medical device approval process

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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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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