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Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
What are the Audit Etiquette Rules I Should be Following? - Featured Image

What are the Audit Etiquette Rules I Should be Following?

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...
Meet a Guru: Jesseca Lyons - Featured Image

Meet a Guru: Jesseca Lyons

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...
Meet a Guru: Taylor Brown - Featured Image

Meet a Guru: Taylor Brown

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over e...
FDA Form 483 Observations and Warning Letters - What’s the Difference? - Featured Image

FDA Form 483 Observations and Warning Letters - What’s the Difference?

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference between the two? Plenty!
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips) - Featured Image

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

As your company heads back from holiday breaks, what’s happening into the New Year?
How to Prepare for the Medical Device Single Audit Program (MDSAP) - Featured Image

How to Prepare for the Medical Device Single Audit Program (MDSAP)

How is your understanding of the Medical Device Single Audit Program (MDSAP)?
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO audito...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Over years of working with medical device companies, we’ve found that there is a particular area tha...

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