greenlight.guru Medical Device Blog

Get the latest updates from our blog:

How to Properly Use the FDA Pre-Submission Process and Why It's So Important - Featured Image

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

In order to get your medical device to market, you will need to know about pre-submissions and the p...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the r...
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development - Featured Image

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

3D printing can impact new product development and manufacturing. It’s a technology that is hot in m...
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...
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...
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...
What Device Makers Need to Know About Design Verification and Validation with Mike Drues - Featured Image

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and ...
Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff - Featured Image

Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incor...
How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso - Featured Image

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Getting started in the medical product development process can be a huge undertaking. You might have...
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...

The greenlight.guru Medical Device Blog

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