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

15 Habits of Highly Effective Regulatory Professionals

By Nick Tippmann on September 12, 2018

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

By Nick Tippmann on August 29, 2018

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

By Nick Tippmann on August 17, 2018

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...

How Human Factors Impact Your Medical Device

By Nick Tippmann on August 8, 2018

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

By Nick Tippmann on August 1, 2018

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?

By Nick Tippmann on July 18, 2018

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

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 ...

CAPA Process Mistakes You Want to Avoid

By Nick Tippmann on March 21, 2018

What are the most common problems for medical device companies with their 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...

Greenlight Guru Medical Device Blog