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What Medtech Startups Should Know About Quality Systems To Not Go Overboard - Featured Image

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

Medtech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory ...
Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner - Featured Image

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

If you are part of an organization developing or producing Class II medical devices, you should know...
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...
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon? - Featured Image

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

As medical device developers, it is our responsibilities to make sure that our products are safe and...
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 ...
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 Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) - Featured Image

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

It’s time to break down the how and why of intended use and indications of use statements for your n...
Is Your Company Disconnected from the Medical Device Regulations It Must Abide By? - Featured Image

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

As I type this post, I must admit that I’m a little perplexed. It seems medical device company after...
The Definitive Guide to Responding to FDA 483 and Warning Letters - Featured Image

The Definitive Guide to Responding to FDA 483 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...

The greenlight.guru Medical Device Blog

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