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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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2025_Hero Clinical
Clinical data collection for medical devices

The only eClinical platform for medical devices

Greenlight Guru Clinical is built to help medical device companies generate high-quality, reliable, and compliant clinical data from every study.

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Trusted by 1000+ medical device companies

Bad data quality can easily ruin a perfectly good study

Data collected on paper or spreadsheets is guaranteed to have errors and may be unusable in submissions. Greenlight Guru eliminates errors for high-quality data from every source.

Built for MedTech

Pharma-first tools don't support medical device studies. In Greenlight Guru, every feature is built for MedTech.

Fast implementation

Start working sooner with a no-code, validated solution and onboarding provided by medical device experts.

Unrivaled visibility

Set up studies in minutes and get real-time views of your data in an intuitive and modern platform.

Any study, anywhere

Use one system for all your clinical data collection—from early feasibility and pivotal studies to PMCF and registries.

Collect data in-house or for clients

For Clinical Teams

Poor data quality puts your entire submission in jeopardy. Get real-time visibility into your studies with a single system built just for MedTech.

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For CROs

Ditch the clunky, pharma-centric systems. Run more studies with less overhead in an eClinical platform your sponsors will love.

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Collect and manage all your clinical data

A single, validated platform with everything you need to run medical device studies

Medical device trials are unique. Greenlight Guru is built to help MedTech companies carry out GCP-compliant studies that generate high-quality clinical data.

Unrivaled data visibility and management

Run faster, smoother studies with real-time insight into study progress and data and workflows that comply with FDA, EU MDR, and ISO 14155:2020 requirements.
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EDC

Collect and manage all your clinical data

A single, validated platform with everything you need to run medical device studies

Medical device trials are unique. Greenlight Guru is built to help MedTech companies carry out GCP-compliant studies that generate high-quality clinical data.

Keep your trials on track

of post-market companies are not equipped to manage their clinical trials
+
When Hemex needed an eClinical platform to help them manage multiple studies and generate submission-ready clinical data, they turned to Greenlight Guru.
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“Greenlight Guru Clinical has had a direct impact on the adherence to timelines for our clinical data collection, study milestones, and market-related milestones, contributing to the overall efficiency and success of our studies.”
— Gheorghe Pop, Medical Monitor & Biostatistician

Study timelines tend to grow. Let’s fix that.

Work in a platform that’s purpose-built to help you start fast, stay on track, and get your data as soon as it’s ready, not weeks later.

Accelerate study
start-up

Build studies in minutes and reuse existing forms and studies in a validated system that’s optimized for MedTech.

Collect compliant and reliable clinical data

Audit trails, Part 11-compliant e-signatures, and workflows aligned with ISO 14155:2020 ensure your data is submission-ready.

A platform your study sites will love

Build better site relationships with a simple and reliable platform that’s designed for easy onboarding and smooth collaboration.

Fewer errors, cleaner data

Spend less time cleaning data with user-friendly forms that enforce response rules and eliminate potential errors.

“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

Frequently asked questions

What types of studies can I run in Greenlight Guru Clinical?

You can use GG Clinical for early feasibility, pivotal trials, PMA studies, post-market surveillance, registries, and PMCF surveys. The platform supports both pre-market and post-market evidence needs for medical device and diagnostic trials.

How long does it take to set up a study?

Most teams are up and running in weeks, rather than months. Our no-code builder, reusable templates, and dedicated onboarding support help you move fast without needing developers or consultants.


Is your platform compliant with ISO 14155 and 21 CFR Part 11, and GDPR?

Yes. GG Clinical is fully aligned with ISO 14155, 21 CFR Part 11, and GDPR. Validation documentation, audit trails, and role-based access controls are built in.

Can I use GG Clinical with external CROs or sponsors?

Yes. CROs and sponsors can collaborate in the platform with role-based access and activity logs. It’s easy to manage visibility across multiple stakeholders while keeping data secure and compliant.

Do you support eConsent, ePRO, and remote data capture?

Yes. GG Clinical includes built-in modules for eConsent, ePRO, and site-based or remote data capture. All are integrated into the same system with real-time oversight.

How do you handle system validation?

We provide complete system validation documentation and support. Our platform is pre-validated so you can skip the long setup process and still stay inspection-ready.

What kind of training and support do you offer?

All customers get hands-on onboarding with our Clinical Gurus, access to our academy, plus ongoing support. Training is tailored to MedTech workflows and includes help with study builds, user roles, and best practices.

Is GG Clinical easy for sites to use?

Yes. The interface is simple and intuitive, even for sites with limited tech experience. Most sites require little to no training to start entering data or reviewing forms.

Can I reuse forms or studies across multiple trials?

Absolutely. You can clone forms, workflows, and full study configurations to save time and ensure consistency across trials.

What makes Greenlight Guru Clinical different from other EDC platforms?

GG Clinical is purpose-built for medtech—not adapted from pharma. It’s fast to launch, easy to use, and built to meet device-specific compliance without customization or complexity.

Do you have the ability to support tracking of safety events (AE's/SAE's)?

Yes, we have a safety module built directly into the system that can be used in any study. We provide templates that get you started quickly but you also have the option of fully customizing to your needs. 

Focus on the work that matters most

Get a personalized software demonstration and see how Greenlight Guru eliminates repetitive, low-value tasks.

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