<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

As an engineer, there’s not a lot that makes me nervous. Going through an FDA / ISO audit? That make...
Tips to Help You Prepare for an FDA Inspection - Featured Image

Tips to Help You Prepare for an FDA Inspection

No one looks forward to having the FDA come to inspect their facility, but you always need to be rea...
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.
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
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...
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...

The Greenlight Guru Medical Device Blog

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

Our Most Popular Posts

Topics

See More Topics...