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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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Electronic data capture (EDC) for MedTech companies

Collecting and Managing
Clinical Data

From pre-market clinical trials to post-market surveillance, you need a clinical data solution that covers the entire medical device lifecycle. Built specifically for MedTech, Greenlight Guru Clinical makes it easy to build studies and collect clinical data while
staying GCP-compliant.

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Collect Clinical Data Through the Entire Device Lifecycle

Data collection tools for all your key clinical milestones

Feasibility and Usability Studies
  • Kick off your clinical studies with confidence—whether it’s with first-in-human, feasibility, or other pilot-stage clinical studies.
  • Build studies on your own or get help from our in-house experts.
  • Save forms and study builds to reuse on later studies.
Pre-Market Clinical Investigations
  • Accurately capture high-quality safety and effectiveness data for regulatory submissions from pivotal studies and other clinical investigations.
  • Collect and manage clinical data from any source—clinicians, patients or other users.
  • Get real-time visibility into your data with a powerful reporting module and custom study dashboards.
Post-Market Clinical Follow-Up
  • Easily send post-market surveys via email, SMS, or QR code, reuse previous study builds, and continuously capture data once your device is on the market.
  • All your data lives within one system—no matter how you decide to collect it.
  • Get GCP compliant, mobile-first data collection to collect high-quality data in post-market settings.



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

Built Specifically For Medical Device Clinical Trials

Medical device trials are unique. That’s why we built Greenlight Guru Clinical with:

Multiple ways to capture data

Never miss a data point with eCRF, ePRO, surveys, and ad hoc collection.

Built-in compliance

Our system is compliant with Medtech-specific FDA and EU regulations, as well as ISO 14155:2020.

A modern, easy-to-use interface

Get up and running using our 3-step study builder—no coding required.

Easy adjustments to study designs

Make changes based on the requirements of different countries and EC or IRB approvals.

Support for all your clinical activities, every step of the way

E-consent and FDA Part 11-compliant software.

Use patient friendly and regulatory-compliant eSignature methods that allow subjects to sign informed consent digitally.
Built-in Good Clinical Practice (GCP) templates.

Take the stress out of compliance with our ready-to-use and customizable compliance document templates.
Powerful data reporting capabilities.

Always stay up-to-date on the completion status of data events or essential forms with real-time reports that provide you with a comprehensive overview of your studies.
Survey support for 45+ languages.

Ensure the highest-quality data from your post-market surveys by allowing patients and clinicians to respond in the language they feel most comfortable using.

Built for Customers Like You

“Our partnership with Greenlight Guru has meaningfully influenced our success by directly impacting operations efficiency and adherence to timelines.”
Lucie Pribylova
Commercial Operations, HEMEX
“Data monitoring is much easier now than it was before. It's much easier to follow the participant flow and see the status of each participant. Before, we had to write to the site and ask for that status.”
Sarah Nygaard Jensen
Clinical Project Manager, InnoCon Medical
“Having everything-informed consent, randomization, and the eCRFs and ePROs- all in one system makes it much easier to finish the study on time. The teams at our study sites also really value that they don't have to work with more than one system.”
Heiða Bragadóttir
Clinical Trial Manager, Sidekick Health
“The requirements for medical devices are very different from the requirements of pharmaceutical trials, so we needed and EDC solution specifically for medical devices.”
Martijn Dekkers
Clinical Research Manager, Medartis

The best medical devices start with the best clinical evidence.

It all starts with the right tools.

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500 +

MEDTECH CLINICAL TRIALS

study setup in 2-3

weeks

support for 40 +

languages
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