Thought Leadership

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

April 8, 2021

What’s the Difference Between a Class I and Class II Medical Device?

One of the most common questions when it comes to medical device regulation is, “What is the difference between a Class I and Class II medical device?” Today, we will explore the topic in more...

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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

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....

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Thought Leadership

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

What’s the Difference Between a Class I and Class II Medical Device?

5 Mistakes Medical Device Startups Make

Implanted Drug Delivery System

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