Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

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

By Jon Speer on February 21, 2020

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...

Creating an Effective Quality Culture that Benefits Your Patients

By Nick Tippmann on May 20, 2018

We all want medical devices that improve the quality of life for patients, right?

Quality Management Audit or Assessment?

By Larry Mager on March 12, 2018

What's the difference between the two? Plenty!

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018

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)

By Jon Speer on June 5, 2017

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

By Jon Speer on February 11, 2017

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)

By Jon Speer on June 8, 2016

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

By Nick Tippmann on May 23, 2016

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

By Jon Speer on May 16, 2016

When was your last FDA inspection?

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

By Jon Speer on January 13, 2016

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

By Jon Speer on August 31, 2015

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

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