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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...
Aligning True Quality and Compliance with MDDAP - Featured Image

Aligning True Quality and Compliance with MDDAP

What does true quality mean? How does it relate to compliance?
Why Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

Does your medical device company use a third-party or contract manufacturer?
Explaining the Significance of Voluntary Consensus Standards - Featured Image

Explaining the Significance of Voluntary Consensus Standards

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 - 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!
Medical Device Industry Predictions for 2019 - Featured Image

Medical Device Industry Predictions for 2019

It’s time to recap what happened in the medical device industry this year and start to think about w...
Defining Your Medical Device Design Records - Featured Image

Defining Your Medical Device Design Records

It’s easy to get a bit confused when you consider the records that are required for your medical dev...
6 Predictions for the Medical Device Industry in 2019 (and how you can prepare) - Featured Image

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

Within the past couple of years, we have experienced significant changes in the medical device indus...
FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
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...

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