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

The New Special 510(k)

By Nick Tippmann on November 7, 2018

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...

What's New With PMAs

By Nick Tippmann on October 31, 2018

How do you feel about pre-market approval (PMA) for Class III medical devices?

7 Habits of Highly Effective True Quality Medical Device Professionals

By Nick Tippmann on October 17, 2018

What is true quality? How do you achieve it?

What You Need to Know About The FDA CDRH Experiential Learning Program

By Nick Tippmann on September 26, 2018

FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...

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...

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...

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