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Tips for Avoiding Problems with the First-In-Human Study Process - Featured Image

Tips for Avoiding Problems with the First-In-Human Study Process

When it comes to moving from the conceptual phase of developing a medical device and actually doing ...
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...
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...
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...
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 ...
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...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

  Risk management for medical devices from a regulatory and product development perspective is the t...
How To Improve Your Design Reviews (Bonus Episode) - Featured Image

How To Improve Your Design Reviews (Bonus Episode)

Medical device design reviews - are more or less better? What about independent reviews? Are they ne...
How To Improve Your Medical Device Design Reviews - Featured Image

How To Improve Your Medical Device Design Reviews

"Medical device Design Reviews are critical steps within your design and development process.  They ...
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? - Featured Image

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Superbugs.  Reprocessing. The White House. And Design Controls. Probably not a combo of topics you s...
[Podcast] Best Practices for Implementing Design Controls for the Medical Device Industry - Featured Image

[Podcast] Best Practices for Implementing Design Controls for the Medical Device Industry

If you're like many in the medical device industry, you've probably had some questions at one time o...

The greenlight.guru Medical Device Blog

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