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

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

By Nick Tippmann on July 18, 2018

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...

A Guide to Bridging User Needs Into Design Requirements

By Jon Speer on July 16, 2018

“The answers are only as good as the questions we ask!”

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

By Nick Tippmann on July 12, 2018

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...

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

By Nick Tippmann on May 15, 2018

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...

How to Ensure Your Quality Management System is Effective and Benefits Patients

By Nick Tippmann on April 19, 2018

When it comes to quality management compliance, would you consider yourself a box checker or a true ...

5 Most Common Problems With Your CAPA Process

By Nick Tippmann on March 21, 2018

What are the most common problems with the CAPA process?

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

By Nick Tippmann on February 21, 2018

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

By Nick Tippmann on January 10, 2018

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...

Common Mistakes That Can Tank Your FDA 510(k) Submission

By Nick Tippmann on November 16, 2017

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

By Nick Tippmann on November 8, 2017

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...

Lessons to Be Learned from Recent FDA Inspections

By Nick Tippmann on October 18, 2017

Something that you might find surprising is the number of medical device companies that are simply n...

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

By Nick Tippmann on August 30, 2017

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...

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