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Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
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 aud...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

The FDA has arrived at your premises…
How to Prepare Your Design History File (DHF) for an FDA Inspection - Featured Image

How to Prepare Your Design History File (DHF) for an FDA Inspection

  So, the FDA is coming to inspect your medical device company. If you’re confident that you have ev...
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? You may believe that the likelihood of an FDA inspection happenin...
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. And if you’re...
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...
An FDA Inspection Will Happen - Featured Image

An FDA Inspection Will Happen

If you are a medical device company in the U.S., did you know FDA is required to inspect all class I...

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