Filter All Blog Posts

MedTech Lifecycle Excellence

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

September 21, 2023
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD)... Read More
Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Product Development

Ultimate Guide to Device Class Requirements under EU MDR

September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
MedTech Lifecycle Excellence

From Academia to FDA Clearance (True Quality Roadshow - Boston)

September 14, 2023
In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Establishing a QMS

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

September 1, 2023
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning... Read More
Regulatory Submission

MedTech Funding and Preparing for Due Diligence

August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More
Regulatory Submission

Exploring Breakthrough Device Designation

August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.


Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

Elevate Your Education

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

Find Your Community
Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

Become a Partner

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

Explore Our Content Hub