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

Explaining the Significance of Voluntary Consensus Standards

By Nick Tippmann on January 2, 2019

What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...

FDA Plans to Modernize 510(k) - Is the Sky Falling?

By Nick Tippmann on December 5, 2018

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...

Understanding the Blurred Lines Between Consumer Tech and MedTech

By Nick Tippmann on November 28, 2018

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...

Understanding The Differences Between Clearance vs Approval vs Granted

By Nick Tippmann on November 21, 2018

Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or m...

The New Special 510(k): What You Need To Know

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...

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