Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

When to Throw the Least Burdensome Flag on FDA

By Nick Tippmann on October 6, 2021

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform

By Nick Tippmann on August 13, 2021

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...

Centese Trades in Paper-based QMS for Medical Device Success Platform & Achieves 510(k) Clearance

By Nick Tippmann on June 22, 2021

For many early-stage medical device companies, the default option when implementing a quality manage...

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

By Tom Rish on May 23, 2021

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...

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

By Nick Tippmann on May 6, 2021

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

By Jesseca Lyons on April 25, 2021

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

By Nick Tippmann on March 31, 2021

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

How to Demonstrate Substantial Equivalence in 5 Easy Steps

By Tom Rish on March 7, 2021

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

By Nick Tippmann on March 1, 2021

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?

By Wade Schroeder on February 21, 2021

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

By Jon Speer on January 25, 2021

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...

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