Medical Device Quality, Regulatory and Product Development Blog

Top 35+ Medical Device Conferences To Attend in 2019

By Nick Tippmann on January 29, 2019

Simply attending the right conferences can be a game-changer for those in the medical device industr...

Introducing The Greenlight Guru True Quality Roadshow 2019

By Jon Speer on January 29, 2019

To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our lead...

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...

Best Practices for Effective Medical Device Design Reviews

By Jon Speer on January 20, 2019

Design Reviews are intended to be checkpoints during medical device product development to ensure th...

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...

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

By Stephanie Christopher, MA, Program Director, Case for Quality & Science of Patient Input on January 13, 2019

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...

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?

Why Contract Manufacturers Shouldn't Own Your Quality System

By Jon Speer on January 7, 2019

Does your medical device company use a third-party or contract manufacturer?

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 Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019

Top 10 Most Popular Greenlight Guru Posts of 2018 - Featured Image

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...

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