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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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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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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
Product Development

What is a Modern QMS?

Etienne Nichols
May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

Greenlight Guru
May 24, 2023
Yes way, San Jose! On April 20th, the Greenlight Guru True Quality Roadshow landed in San Jose, California for its second stop of the 2023 tour. Unsurprisingly, the Bay Area... Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

Etienne Nichols
May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
MedTech Lifecycle Excellence

Ad Promo and The Difference in Regulatory & Legal

Etienne Nichols
May 24, 2023
What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it... Read More
Product Development

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

Jon Bergsteinsson
May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
MedTech Lifecycle Excellence

How AI Can Help You Manage Risk

Etienne Nichols
May 17, 2023
With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and... Read More
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

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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