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Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

We all want medical devices that improve the quality of life for patients, right?
FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

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

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference between the two? Plenty!
4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

The safety and efficacy of your product rides heavily on the quality of the components that make it ...
How To Prepare for an FDA Inspection (Plus 5 Tips) - Featured Image

How To Prepare for an FDA Inspection (Plus 5 Tips)

Over the past several years, FDA has been more aggressive and active in performing medical device co...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included) - Featured Image

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

Attention: If you are a medical device company and you have class II or class III products registere...
Tips to Help You Prepare for an FDA Inspection - Featured Image

Tips to Help You Prepare for an FDA Inspection

On today’s episode, we’re introducing the newest addition to the Greenlight Guru team, Jesseca Lyons...
Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015 - Featured Image

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

When was your last FDA inspection?
The Definitive Guide to Responding to FDA 483 Observations and Warning Letters - Featured Image

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

Should you ever have an FDA inspection, you’re going to want to know what to do after.
How To Flush $400,000 Down the Drain Fighting the FDA - Featured Image

How To Flush $400,000 Down the Drain Fighting the FDA

How much does it cost to address FDA 483 observation and warning letter issues? Unless you have been...

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