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Platform
The Greenlight Guru Platform

Solutions built for medical device teams to move faster, stay compliant, and grow with confidence.

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Quality Management

Manage quality events, training, and documentation in one place.

Document Management

Control documents, training, and change with traceability.

Quality Events

Track CAPAs, audits, and NCs with audit-ready records.

Suppliers & Operations

Qualify suppliers and manage parts with visibility.

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Product Development

Connect design, risk, and AI-powered traceability as you build.

Requirements Management

Link needs, requirements, and verification to design controls.

Software Release Management

Automate traceability from dev tools for faster releases.

Risk Management

Assess ISO 14971 risk as requirements and tests evolve.

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Clinical Evidence

Oversee studies with connected data, documents, and workflows.

Clinical Trials

Capture compliant clinical data with a validated medical EDC.

PMCF

Plan and manage PMCF aligned to EU MDR expectations.

ePRO/eCOA

Collect clinical outcome data in-person or remotely on any device.

Why Greenlight Guru
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Medical Device Expertise

Built with regulatory insight to help medtech teams move faster with confidence.

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AI, Data, Intelligence

Find issues faster and make smarter decisions with less manual work.
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Learning, Templates. Training

Tools and resources that help teams implement quickly and meet requirements.
Solutions
Customers
Partners
Company
Resources
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QMSR is here! Is your quality system ready?

This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo
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EDC software for medical devices

Medical device
EDC software for
clinical trials

Designed exclusively for medtech, Greenlight Guru Clinical is an easy-to-use, validated EDC platform that helps teams collect reliable, compliant clinical data across pre-market studies,
post-market surveillance, PMCF, and registries.

Request a demo

Trusted by 1000+ medical device companies

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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.

AI-assisted clinical data management for medical device trials
Data locks, event activations, permission assignments across sites and subjects: these are the operations that define the pace of a clinical study. The Greenlight Guru Clinical AI assistant executes structured clinical data management tasks from a plain-language description, working across your full study setup in seconds rather than hours of manual navigation through your EDC.

Every action goes through your review before it runs. Approve, modify, or reject each proposed change. Every approved step is logged in an audit trail built to support ISO 14155 and ICH GCP expectations.

For teams managing multi-site trials or working with CRO partners, AI Data Connect extends this further. Connect the AI tools your team already uses to your electronic data capture data through the same permission model your users have today. Pull subject cohort data, generate monitoring reports, and run analysis without manual exports.

AI Features Clinical

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.

Stop letting paper and spreadsheets put your study at risk

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.

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Built for MedTech

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

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

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

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


Medical device EDC vs. Pharma EDC platforms

Medical device clinical investigations need different evidence workflows than pharma clinical trials. Greenlight Guru Clinical reduces the customization required in pharma-first EDC platforms by supporting device-specific study types, ISO 14155 workflows, Part 11 controls, PMCF data collection, and practical collaboration with research sites.

Study types

Run early feasibility, pivotal, PMA, registry, post-market surveillance, and PMCF studies without forcing teams into drug-trial workflows.

Study build

Use no-code eCRF software and reusable CRF design templates instead of consultant-heavy database builds.

Compliance

Maintain audit trails, role-based access, electronic signatures, and documentation aligned with regulatory standards including ISO 14155 and 21 CFR Part 11.

Site adoption

Give sponsors, CROs, and research sites simple workflows for cleaner data, fewer queries, and smoother monitoring.

 

Keep your medical device clinical trials on track
Track eCRF completion, data verification, monitoring activity, adverse events,
and PMCF follow-up in one clinical data platform built for medtech.

Keep your trials on track

53-percent
of post-market companies are not equipped to manage their clinical trials
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When SOPHiA GENETICSneeded an eClinical platform to help them navigate their first international clinical study, they turned to Greenlight Guru

“It’s been key to our success, and we value not only the services provided, but also the collaborative environment created through open dialogue, mutual feedback, understanding of our challenges, and the responsiveness of the support team.”

Marion
Marion Brayer,
Senior Director of Clinical Operations
SOPHIA GENETICS
Request a Demo

For all your clinical studies

Use one system for medical device clinical data collection, from early feasibility and pivotal investigations to PMCF, registries, post-market surveillance, and investigator-sponsored studies across research sites.

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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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.

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Accelerate study
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Build studies in minutes and reuse existing forms and studies in a validated system that’s optimized for medtech.
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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.
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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.
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Fewer errors, cleaner data

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

Explore the Greenlight Guru Platform

Built by medtech experts and ready for the entire product lifecycle. Whatever stage your device is at, our solutions help you move faster, stay compliant, and bring safe, high-quality devices to market.
Quality management made simple

An AI-powered eQMS built just for medtech and aligned with industry standards. 

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Modern product development tools

Build faster with a compliant, traceable solution that integrates with your dev tools.

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Support from
medtech experts

Get personalized onboarding and on-demand assistance from our legendary Gurus.

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Frequently asked questions

Can I buy Greenlight Guru Clinical without Greenlight Guru QMS?

Yes, Greenlight Guru Clinical is a standalone EDC platform that works independently of Greenlight Guru's QMS.

Is Greenlight Guru Clinical integrated with Greenlight Guru's QMS?

No, there is no integration between Greenlight Guru's EDC and QMS platforms. They are independent of each other.

What is EDC software for medical devices?

EDC software for medical devices is a validated system that helps medtech teams collect, review, and manage clinical data from medical device clinical investigations. It supports eCRFs, monitoring, adverse event reporting, audit trails, 21 CFR Part 11 electronic signatures, ISO 14155-aligned workflows, and PMCF evidence collection.

What should medtech teams look for in EDC software?

Medtech teams should look for no-code CRF design, built-in data validation, reusable eCRF templates, real-time monitoring, AE and SAE tracking, audit trails, 21 CFR Part 11 controls, ISO 14155 support, PMCF workflows, role-based access, secure Data exchange, and an interface that research sites can use with minimal training.

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.

How is medical device EDC different from pharma EDC?

Medical device EDC is built for device-specific clinical investigations and post-market evidence, while pharma EDC platforms are typically optimized for drug-trial workflows. For medtech teams, the EDC should support feasibility studies, pivotal studies, PMCF, registries, ePRO/eCOA, safety events, monitoring, audit trails, and compliance with regulatory standards like ISO 14155 and 21 CFR Part 11 without extensive customization.

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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