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

Design Validation vs. Human Factors Validation

By Nick Tippmann on February 13, 2019

Human factors and risk create a lot of confusion in the medical device industry. What do you need ...

Medical Device Product Development Value Proposition

By Nick Tippmann on February 6, 2019

It doesn’t matter how long a company has been in business. Both startups and established companies n...

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

By Nick Tippmann on January 25, 2019

Regulatory compliance is critically important. However, some think product liability is just as impo...

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

By Nick Tippmann on January 16, 2019

Do you know the difference between quality management system (QMS) and quality systems management (Q...

Aligning True Quality and Compliance with MDDAP

By Nick Tippmann on January 9, 2019

What does true quality mean? How does it relate to compliance?

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...

Medical Device Industry Predictions for 2019

By Nick Tippmann on December 19, 2018

It’s time to recap what happened in the medical device industry this year and start to think about w...

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.

Streamlining The Device Marketing Authorization Process

By Nick Tippmann on November 14, 2018

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (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...

Greenlight Guru Medical Device Blog