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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Clinical Electronic Data Capture (EDC) Software

The Leading Toolbox for MedTech Clinical Data Collection

Greenlight Guru Clinical (formerly SMART-TRIAL) is a single, compliant platform for collection and management of all clinical evidence, safety, and performance data.

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MedTech Clinical Solutions

Every Feature Made for MedTech

Your software is already optimized for medical device studies. That means no coding, no stressful setup, and no expensive pharma-centric features you'll never use.

Pre-validated per FDA and ISO 14155:2020

Ensure compliance from the start with built-in ISO 14155:2020, EU MDR, and FDA requirements. In addition, you'll get 13 ready-to-use and customizable compliance document templates.

Support for multi-indication device studies

Easily make adjustments to your study designs according to different countries' requirements and EC approvals.

Support for dynamic visits and treatments

If your study subjects require one or many treatments with your device, you can use multiple activations for any visit event.

3-Step study builder

Set up a study in as little as 90 seconds with intuitive drag-and-drop elements, form validation, and customizable protocol designs. Adjust and reuse your studies as much as you need to.

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

“When we teach people to use it, they just fly through it, even when they're not used to using systems like this.”
Ragna Björg
Sr Director of Product Management at Kerecis
“It is now super easy and flexible for us to create each page of our eCRF.”
Barbara Simon
Clinical Research Audiologist at Bernafon
“The API connection with our own software saves an incredible amount of internal resources.”
Audrey Plesse
Clinical Project Manager at Cardiologs
“We've managed to cut weeks of work out of our clinical tests.”
Karen Boel
Head of Clinical Audiology and Usability, SIV at Oticon
Clarity Creates Speed.
Ease-of-Use Creates Efficiency.
Compliance Creates Confidence.
Greenlight Guru Clinical eliminates medical device compliance risks by streamlining and simplifying data collection.
Your Old System
Greenlight Guru Clinical
Your Old EDC
Your New EDC
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Platform Tools

Functionality Meets Convenience

Experience versatile tools and customizations that anyone can use and build your study exactly as you need it.

eCRF: Customizable case report forms

Design your eCRF based on your unique study requirements — simple or complex, there are no limits.

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ePRO/eCOA: Secure SMS and Email data collection

Create a user-friendly experience for study subjects and increase response rates, adherence, and quality of data.

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Survey: Pre-validated post-market surveys

Out-of-the-box GCP-compliant surveys. Collect data with dynamic surveys to comply with EU MDR PMCF or FDA Post-Approval requirements.

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Cases: GCP compliant ad hoc data collection

The mobile-first case studies series data collection tool you've always wanted. Clinician-friendly and compliant. Enable ad-hoc data entry of high-quality patient data in post-market settings.

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Add-ons: Build your study toolbox

From eConsent to randomization, custom study dashboards, and external system integrations.

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Watch Us Build a Clinical Study in 90 Seconds:

We'll show you how.

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Designed for MedTech efficiency and growth
Pre-validated for FDA & ISO 14155:2020
Collect clinical evidence from physicians, patients, and other end users
Built-in templates and clinical builder for MedTech
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Greenlight Guru Clinical 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
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Greenlight Guru Clinical 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

Better Clinical Evidence.
Safer Medical Devices.

It starts with the right tools.

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500 +

MedTech Clinical Trials

Study Setup In 2-3

weeks

Support for 40 +

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