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Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
Understanding the Investigational Device Exemption (IDE) Process - Featured Image

Understanding the Investigational Device Exemption (IDE) Process

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...
How to Demonstrate Substantial Equivalence in 5 Easy Steps - Featured Image

How to Demonstrate Substantial Equivalence in 5 Easy Steps

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...
Everything you Need to Know about SaMD from an FDA Perspective - Featured Image

Everything you Need to Know about SaMD from an FDA Perspective

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means - Featured Image

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...
Change Management Process Explained in 6 Easy Steps (+ free template) - Featured Image

Change Management Process Explained in 6 Easy Steps (+ free template)

In Prosci’s research, participants were six times more likely to meet project goals by following an ...
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry - Featured Image

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? - Featured Image

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...
Positive and Negative Impacts of EUA on the Medical Device Industry - Featured Image

Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...

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