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5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
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...
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
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.
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!
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to c...
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...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory aff...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more...

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