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Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory aff...
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

    Have you thought about your systems and processes related to regulatory and quality standards?
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)...
7 Questions About the European MDR Answered - Featured Image

7 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) - Featured Image

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

Students offer hope for our future. They will be developing products that can save our lives, or at ...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

Every medical device developer would like to take the fastest path to market, right? Sometimes the k...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.
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...
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare) - Featured Image

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

There is an old saying that the only thing that is constant in life is change. For the medical devic...

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