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

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

By Nick Tippmann on April 26, 2019

Within the medical device industry, there’s a right way and a wrong way to address quality and compl...

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

By Nick Tippmann on April 19, 2019

Do you love quality and regulatory and keeping up with all things related to the medical device indu...

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

By Nick Tippmann on April 7, 2019

How do medical device companies approach the “scaries” related to quality and guidance regulations w...

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

By Nick Tippmann on April 7, 2019

Premature birth is the #1 cause of infant mortality in the United States. Improving the quality of l...

Quality, Fast, Cheap...Pick Two

By Mark D Proulx, CQA, cSSBB on February 24, 2019

You may think you're saving the company money by using that "free" Excel spreadsheet to track design...

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 17, 2019

One thing that seems to be constant in the global medical device industry is change.

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...

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

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

By Mark D Proulx, CQA, cSSBB on October 28, 2018

Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Ma...

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