Moving MedTech Forward

Greenlight Guru provides medical device companies with industry-leading software to scale faster, become more efficient, and reduce risk throughout the product lifecycle.

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The #1 QMS software purpose-built for medical device companies.

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The leading toolbox for MedTech clinical trial data collection.

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1,100+ of the world’s leading MedTech companies trust Greenlight Guru:

Helping MedTech innovators get faster and more efficient.

35 %

Reduction in Time to Market

2000 +

ISO 13485 Certifications

50 %

Reduction in Time Preparing
for Audits

500 +

Clinical Studies Completed

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Greenlight Guru Quality

Rethink What Your QMS Can Do

Upgrade your paper-based or generic QMS to a modern, cloud-based solution that enables you to track quality events, trace design controls to risk, ensure compliance, and more.

Our QMS software helps you bring medical devices to market faster and keeps them on the market longer.

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Greenlight Guru Clinical

A Smarter Way To Collect and Manage Clinical Data

Collect and manage all clinical evidence, safety, and performance data within one versatile digital toolbox.

Modernize your process to cut weeks out of the clinical testing process and bring safer products to market.

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Guru Services

Hands-on guidance from Experienced MedTech professionals

Greenlight Guru offers much more than software. Benefit from 1:1 human support covering regulations, risk reduction, software guidance, and business roadblocks.

Harness our 500+ years of combined industry experience to confidently meet your objectives at any stage of your journey.

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Our Customers Say It Best

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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations, Photonicare

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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations, Critical Care Diagnostics, Inc.

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Greenlight Guru Clinical (formerly SMART-TRIAL) helps us do better tests and faster tests. It will open up new opportunities in the way we do testing at Oticon.

Jacob Anders Roug Technical Audiologist, Oticon

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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations, Photonicare

See More Customer Case Studies

Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations, Critical Care Diagnostics, Inc.

See More Customer Case Studies

Greenlight Guru Clinical (formerly SMART-TRIAL) helps us do better tests and faster tests. It will open up new opportunities in the way we do testing at Oticon.

Jacob Anders Roug Technical Audiologist, Oticon

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Explore Our Top Resources

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Step-by-step guide to building the business case for your new eQMS solution, pitching it to management, and making the transition from your old QMS to one that will help your MedTech business thrive.

Read the Guide

2024 MedTech Industry Benchmark Report

In our fifth annual medical device benchmark report, we surveyed over 500 medical device professionals to better understand industry-wide trends, shifting priorities and strategies, commercialization challenges, and best practices shaping the MedTech industry.

Download the Report

Ultimate Guide to ISO 14155:2020 for Medical Devices

Dive into ISO 14155:2020, the cornerstone of Good Clinical Practice (GCP) for medical device trials. Uncover the latest updates, learn how to improve risk management, and discover how to streamline compliant electronic data capture.

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Focus on the Work That Matters Most.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

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Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

Moving MedTech Forward

1,100+ of the world’s leading MedTech companies trust Greenlight Guru:

Rethink What Your QMS Can Do

A Smarter Way To Collect and Manage Clinical Data

Hands-on guidance from Experienced MedTech professionals

Our Customers Say It Best

Explore Our Top Resources

Focus on the Work That Matters Most.

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

Moving MedTech Forward

You're Almost There...

1,100+ of the world’s leading MedTech companies trust Greenlight Guru:

Rethink What Your QMS Can Do

A Smarter Way To Collect and Manage Clinical Data

Hands-on guidance from Experienced MedTech professionals

Our Customers Say It Best

Explore Our Top Resources

Focus on the Work That Matters Most.