Medical Device Design Industry Blog

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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.

Notes reading FDA recall signify the consequences of medical device failure

Author: Carrie Hetrick | 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 Hetrick | 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 Hetrick | 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...

Author: Keith Handler | December 20, 2021

Why Medical Device Cybersecurity Matters

In our post-pandemic, socially distant world, tech-enabled distributed healthcare has become ubiquitous. As medical devices get more advanced to support this evolving landscape, so do the...

Author: Carrie Hetrick | December 20, 2021

A Guide to FDA Design Controls for your Medical Device

Medical devices hold great responsibility and risk – if they aren’t working properly, there could be dire consequences for a person’s health and potentially life. Because of this, they are...

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...

Author: Carrie Hetrick | 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...

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...

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...

Resources

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...

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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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Medical Device Design Industry Blog

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

Why Medical Device Cybersecurity Matters

A Guide to FDA Design Controls for your Medical Device

Strategies for Navigating Medical Device FDA and CE Approval

Understand Quality Systems Regulations to Avoid FDA Enforcement Actions

Applying human factors and usability engineering to medical devices

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

Resources

FDA Medical Device Regulation Guidance for 2022

5 Mistakes Medical Device Startups Make

Scalp Cooling System

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