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

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

By Nick Tippmann on March 12, 2020

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019

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A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...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

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