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A Step-by-Step Guide to Preparing Your FDA 510(k) Submission - Featured Image

A Step-by-Step Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru - Featured Image

MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru

For any startup medical device company, the road to FDA 510(k) clearance can be fraught with any num...
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important - Featured Image

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 5...
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It - Featured Image

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

  My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the m...
What do You Need to Know about the 510(k) Submission Process - Featured Image

What do You Need to Know about the 510(k) Submission Process

Have you ever been through the experience of having the FDA refuse to accept your 510(k)? This has h...
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission - Featured Image

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

It can be confusing to know which submission type is the correct one for your particular development...
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...

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