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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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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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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HubSpot Video

Clinical Electronic Data Capture (EDC) Software

The Swiss Army Knife of MedTech Clinical Data Collection

Collect clinical evidence, safety, and performance data for any activity, throughout your entire medical device lifecycle. All within one compliant platform.

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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
Clarity Creates Speed.
Ease-of-Use Creates Efficiency.
Compliance Creates Confidence.
SMART-TRIAL by Greenlight Guru eliminates medical device compliance risks by streamlining and simplifying data collection.
Your Old System
Smart-Trial by Greenlight Guru
Your Old EDC
Your New EDC
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1,000+ 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
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
HubSpot Video

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

Support for dynamic visits and treatments
HubSpot Video

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
HubSpot Video

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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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
HubSpot Video

 

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
HubSpot Video

 

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
HubSpot Video

 

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
HubSpot Video

 

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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HubSpot Video

 

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Watch Us Build a Clinical Study in 90 Seconds:

HubSpot Video

We'll show you how.

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https://blog.greenlight.guru/hubfs/Oticon%20-%20SMART-TRIAL%20by%20Greenlight%20Guru%20Case%20Study.png play

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
https://blog.greenlight.guru/hubfs/Oticon%20-%20SMART-TRIAL%20by%20Greenlight%20Guru%20Case%20Study.png play

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

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 +

Languages