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15 HABITS OF HIGH EFFECTIVE QUALITY AND REGULATORY PROFESSIONALS - Featured Image

15 HABITS OF HIGH EFFECTIVE QUALITY AND REGULATORY PROFESSIONALS

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
What you need to know About FDA’s Progressive Programs - Featured Image

What you need to know About FDA’s Progressive Programs

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...
The Bleeding Edge: Lessons Learned for the Medical Device Industry - Featured Image

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...
How to Think About Quality and Regulatory as Your Company Scales - Featured Image

How to Think About Quality and Regulatory as Your Company Scales

As companies transition from being a start-up or small company to a more established business and br...
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...
A Guide to Bridging User Needs Into Design Requirements - Featured Image

A Guide to Bridging User Needs Into Design Requirements

  “The answers are only as good as the questions we ask!”
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

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

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) - 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...
How to Ensure Your Quality Management System is Effective and Benefits Patients - Featured Image

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

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 - Featured Image

5 Most Common Problems With Your CAPA Process

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 - 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...

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