greenlight.guru Medical Device Blog

Get the latest updates from our blog:

8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a l...
Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor - Featured Image

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for y...
How Design Controls Apply to a 510(k) - Featured Image

How Design Controls Apply to a 510(k)

If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Medical Device Product Development Project Management Best Practices with Peter Sebelius - Featured Image

Medical Device Product Development Project Management Best Practices with Peter Sebelius

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the fo...
How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls - Featured Image

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

Click here to enlarge image. The story I’m about to tell you is about Eddy Engineer and his trials a...
The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

This eBook was originally published as a guest expert three, part, series on Med Device Online.   Yo...
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

This article was originally published on Med Device Online as part of my guest expert series. You ca...
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey - Featured Image

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken - Featured Image

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...

The greenlight.guru Medical Device Blog

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