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

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

Premature birth is the #1 cause of infant mortality in the United States. Improving the quality of l...
Quality, Fast, Cheap...Pick Two - Featured Image

Quality, Fast, Cheap...Pick Two

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 - Featured Image

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

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? - Featured Image

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

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 - Featured Image

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

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

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

Top 10 Most Popular Greenlight Guru Posts of 2018

Thank you for helping make 2018 another big and exciting year for Greenlight Guru!
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

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

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) - Featured Image

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

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

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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