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

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

What to Expect During an FDA QSIT Inspection

By Jon Speer on February 17, 2019

You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...

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

By Jon Speer on April 30, 2018

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

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

By Jon Speer on November 6, 2017

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...

Standard Conformity or Regulatory Compliance? Distinguishing the Two

By Jon Speer on October 9, 2017

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...

FDA Inspections and ISO Audits: What is the Difference?

By Jon Speer on September 18, 2017

It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO audito...

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

By Jon Speer on August 28, 2017

FDA has arrived at your premises…

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

By Jon Speer on July 23, 2017

So, the FDA is coming to inspect your medical device company.

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...

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...

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

By Jesseca Lyons on May 24, 2016

As an engineer, there’s not a lot that makes me nervous. Going through an FDA / ISO audit? That make...

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