greenlight.guru Medical Device Blog

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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...
How To Reduce & Prevent Medical Device Complaints - Featured Image

How To Reduce & Prevent Medical Device Complaints

Congratulations! You have successfully launched a new medical device after months and months of prod...
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...
Design Controls are the #1 Most Cited Issue with FDA - Featured Image

Design Controls are the #1 Most Cited Issue with FDA

Did you know that Design Controls were the #1 issue cited by FDA during 2013? Of the 4000+ 483 inves...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.