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

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019

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

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

By Jesseca Lyons on July 20, 2018

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...

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

By Mary Beth Privitera, PhD, FIDSA on June 18, 2018

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018

Every medical device developer would like to take the fastest path to market, right?

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

By Jon Speer on September 24, 2017

Have you ever been through the experience of having the FDA refuse to accept your 510(k) submission?...

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

By Jon Speer on August 13, 2017

So, you haven’t completed your design controls or design history file (DHF)...

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

By Jon Speer on August 8, 2017

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

By Jon Speer on June 9, 2017

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

The Business Case for Integrated Design Controls

By Jon Speer on November 20, 2016

What role do you believe design controls play in the growth and stability of your company? I suspect...

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

By Jon Speer on August 15, 2016

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...

How Design Controls Apply to the 510(k) Process

By Jon Speer on March 14, 2016

If you are developing a medical device for the U.S. market, you first need to determine how your dev...

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