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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...
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?
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

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...
Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices - Featured Image

Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices

            TABLE OF CONTENTS What is ISO 13485 Evolution of a Quality Management System ISO 13485 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...
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...
Quality vs Compliance Metrics (and what's next for FDA's Case For Quality) - Featured Image

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

What is the FDA looking to drive forward in its Case for Quality initiative? 
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

Would you describe your company as quality focused?
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

  Have you thought about your systems and processes related to regulatory and quality standards?

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