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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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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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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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Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: Houston Recap

Greenlight Guru
April 12, 2023
Thank you, Houston!  The 2023 True Quality Roadshow got off to an exciting start on March 9th, as Greenlight Guru, along with sponsors Velentium and Rook Quality Systems,... Read More
Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

Etienne Nichols
April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More
Establishing a QMS

“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report

Etienne Nichols
April 6, 2023
Greenlight Guru is honored to announce that it has been selected - by users - as the leading QMS for the eighteenth consecutive quarter in G2’s Spring 2023 QMS Grid Report. Read More
MedTech Lifecycle Excellence

Systematic Literature Review for EU MDR

Etienne Nichols
April 5, 2023
What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps?  In today’s episode, you’ll hear from Co-Founder and... Read More
Product Development

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

Jon Bergsteinsson
April 5, 2023
Patient reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more... Read More
MedTech Lifecycle Excellence

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

Greenlight Guru
April 4, 2023
  Take a moment to recognize how much meaningful data lives in your Quality Management System (QMS), spanning multiple processes across quality, product development,... Read More
MedTech Lifecycle Excellence

Greenlight Guru Introduces Export API for a Connected Quality Management System

Greenlight Guru
April 4, 2023
MedTech companies can now connect quality system data with other third-party software. Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
April 2, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Product Development

eBOM vs mBOM: What’s the Difference?

Niki Price
March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. 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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