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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)...
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - Featured Image

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...
Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

  We all want medical devices that improve the quality of life for patients, right?
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

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...
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...
Top 30+ Medical Device Conferences You Should Be Attending in 2018 - Featured Image

Top 30+ Medical Device Conferences You Should Be Attending in 2018

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

The FDA has arrived at your premises…
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...
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

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

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

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