greenlight.guru Medical Device Blog

Get the latest updates from our blog:

The Ultimate Guide to Preparing Your FDA 510(k) Submission - Featured Image

The Ultimate Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

2016 was a very active and monumental year for the medical device industry. There were several impor...
2016 Medical Device Regulatory Trends Year in Review - Featured Image

2016 Medical Device Regulatory Trends Year in Review

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
An Introduction to FDA 21 CFR Part 11 - Featured Image

An Introduction to FDA 21 CFR Part 11

Every week that goes by, I talk to several medical device companies all over the world who have esta...
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) - Featured Image

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

FDA Pre-submissions: They're a hot, timely topic.
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
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 ...

The greenlight.guru Medical Device Blog

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