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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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Establishing a QMS

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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Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

Etienne Nichols
May 16, 2023
Medical devices are intended to save and improve quality of life. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

Ben Bancroft
May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

What is the Best Way to Structure a Risk Management File?

Niki Price
May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

Etienne Nichols
May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
May 11, 2023
Read More
Establishing a QMS

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

Etienne Nichols
May 10, 2023
As a medical device manufacturer, your quality management system (QMS) is the heart of your operations.  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
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

Experience the Guru Edge

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

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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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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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