Filter All Blog Posts

Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
MedTech Lifecycle Excellence

28 Days To Save The World - True Quality Roadshow

August 10, 2023
During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
MedTech Lifecycle Excellence

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

August 3, 2023
In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. Read More
MedTech Lifecycle Excellence

The Right Way to Start a QMS: When, How, & What

July 28, 2023
Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start,... Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

July 21, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More
MedTech Lifecycle Excellence

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

July 20, 2023
In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine... Read More
MedTech Lifecycle Excellence

Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation

July 18, 2023
The company’s recent product launches have helped fuel continued success as large global MedTech companies adopt its solutions. Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... 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