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.

Professional calculating medical device finances.

Author: Carrie Britton | August 22, 2023

FDA Medical Device User Fees (MDUFA) for 2024

On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...

Medical professional on the computer analyzing medical device software.

Author: Jamme Tan | July 14, 2023

Insight on Updated FDA Device Software Guidance

The US Food and Drug Administration (FDA) recently issued a new guidance document: Content of Premarket Submission for Device Software Functions. The revamp of the FDA’s software guidance for...

Graphic that breakdowns the meaning behind a design history file and medical device development.

Author: Erik Hilliard | June 14, 2023

Design History Files: Everything You Should Know

Are you confused when it comes to understanding Design History Files (DHFs)? You're not alone. The complexities of Design History Files for medical devices can be intimidating, but once you...

Woman using modern glucose monitor connected to laptop

Author: Matthew Calloway | June 6, 2023

First, Do No Harm: Ensuring Medical Device Connectivity Solutions are Safe and Secure

Digital health solutions, like wireless technology in healthcare and medical devices that use Wi-Fi, have, and will continue to transform healthcare. They enhance patient experiences, such as...

Author: Ashish Salunkhe | June 3, 2023

MDR Requirements for Post-Market Surveillance: Best Practices and Compliance Strategies

Struggling to keep up with post-market surveillance requirements for your medical devices? Do you worry about the potential risks and liabilities that come with failing to properly monitor...

Author: Tara Miller | May 16, 2023

Who Needs a Q-Sub, and When?

So many questions come up when developing a medical device. What is its intended purpose? Who will use it? How will it be used? What do we need to do? Questions surrounding the medical device...

Medical professional holding medical quality assurance icons

Author: Carrie Britton | May 5, 2023

Medical Device Quality Management: One Size Does Not Fit All

Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable...

Doctor using tablet for medical research development.

Author: Indre Larson | April 18, 2023

Do You Want FDA Breakthrough Device Designation?

Established in 2015, the Breakthrough Devices Program replaced the Expedited Access Pathway and Priority Review for medical devices. The designation of a product as a breakthrough medical device...

Medical professional in lab testing using in vitro diagnostics.

Author: Carina Fleming | April 18, 2023

Deciphering In Vitro Diagnostics (IVD) Medical Device Regulations

Navigating the complex global matrix of in vitro diagnostics (IVD) regulations is a daunting task. It's time-consuming, complicated, and often expensive - and mistakes can be costly! To simplify...

Resources

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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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

Breathing Pacemaker

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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Medical Device Design Industry Blog

FDA Medical Device User Fees (MDUFA) for 2024

Insight on Updated FDA Device Software Guidance

Design History Files: Everything You Should Know

First, Do No Harm: Ensuring Medical Device Connectivity Solutions are Safe and Secure

MDR Requirements for Post-Market Surveillance: Best Practices and Compliance Strategies

Who Needs a Q-Sub, and When?

Medical Device Quality Management: One Size Does Not Fit All

Do You Want FDA Breakthrough Device Designation?

Deciphering In Vitro Diagnostics (IVD) Medical Device Regulations

Resources

Minimally Invasive Devices

5 Mistakes Medical Device Startups Make

Breathing Pacemaker

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