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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Product Development
Etienne Nichols
May 11, 2023

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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MedTech Lifecycle Excellence

Leaning into Lean Documentation

Etienne Nichols
June 7, 2023
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for... Read More
MedTech Lifecycle Excellence

Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies

Greenlight Guru
June 6, 2023
New research demonstrates how modern solutions can significantly improve speed and efficiency while reducing risk for medical device companies.. Read More
Product Development

How to Plan and Budget for MedTech Clinical Activities

Jon Bergsteinsson
June 5, 2023
For years, medical device manufacturers have treated clinical data as a regulatory burden—a low-priority obligation that doesn’t garner much attention. Why? It’s primarily... Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Jesseca Lyons
June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

Jeff Perkins
June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
MedTech Lifecycle Excellence

Cybersecurity and the Future of MedTech

Etienne Nichols
June 2, 2023
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies

Greenlight Guru
June 1, 2023
The risk-based approach to software validation will help customers efficiently and effectively assure compliance when implementing Greenlight Guru software. Read More
Product Development

Managing Major Changes to Medical Device Packaging

Etienne Nichols
May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Product Development

5 Tips for Designing a Medical Device Study Under FDA Requirements

Páll Jóhannesson
May 26, 2023
Let’s face it—medical device clinical studies are no walk in the park. There are so many variables to consider, such as patient recruitment, study design, and regulatory... 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.

Academy

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.

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Community

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.

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Partner Ecosystem

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

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Resources

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.

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