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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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MedTech Lifecycle Excellence

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

Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry

Greenlight Guru
May 9, 2023
First-of-its-kind Risk Solutions pairs AI-generated insights with the only intuitive and ISO 14971:2019 compliant risk management software to help medical device companies... Read More
Product Development

How to use the SMART-TRIAL AE/SAE reporting module

Páll Jóhannesson
May 8, 2023
This blog post highlights the ready-to-use SMART-TRIAL module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module benefits... Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

Etienne Nichols
May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
MedTech Lifecycle Excellence

Complaint Handling with Medical Device Guru, Brittney McIver

Etienne Nichols
May 3, 2023
What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps... Read More
Product Development

Why Clinical Data Is Essential to Value-Based Healthcare

Páll Jóhannesson
May 1, 2023
The healthcare industry in many countries is undergoing a transition. We’re moving away from a strict focus on the upfront cost of care to what’s known as “value-based”... Read More
Product Development

3 Things to Love about Internal Audits

Sara Adams
April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
MedTech Lifecycle Excellence

HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies

Greenlight Guru
April 27, 2023
Expanded partnership will galvanize MedTech companies’ push to improve the quality of life. Read More
MedTech Lifecycle Excellence

Avoiding Potential Issues with your 510(k) Submission

Etienne Nichols
April 27, 2023
When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the... Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

Etienne Nichols
April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. 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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