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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 CAPA Management Audit Management Product Development

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

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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Clinician-Friendly Ad-Hoc Data Entry

GCP Compliant Ad-Hoc Data Collection

The ideal clinician-friendly, GCP compliant, mobile-first data collection tool for high-quality data in post-market settings.

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1,000+ of the world's leading MedTech companies trust Greenlight Guru.

Superior Ad-Hoc Data Capture

Collecting GCP compliant ad-hoc data has been a tough nut to crack for many medical device manufacturers – Greenlight Guru Clinical's Cases module is here to fix that. Empower clinical staff to easily deliver data either during or after application of a medical device in practice, and ensure fresh-in-mind data while minimizing their burden.

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Simple and Compliant Prospective Data Collection

Greenlight Guru Clinical Cases is specifically designed to enable device manufacturers to collect high quality and compliant ad-hoc prospective data in post-market settings.

Patient-Specific Data Collection

A unique feature of Greenlight Guru Clinical Cases is the ability to easily collect data specific to individual patients. 
Identify Safety Concerns in Real Time

Track survey responses in real-time to monitor response rates, analyze data, and quickly identify or get notified with potential safety concerns with your device.
Ensure Traceability


All data inputs automatically include automatic user identification to ensure full traceability of where all data came from and who entered it.
Simplify Clinical Data Compliance

The existing quality management processes at Greenlight Guru Clinical simplify compliance with ISO 14155:2020, FDA CFR 21 Part 11 and EU GDPR by taking care of system validation and specification requirements

Simplified Post-Market Ad-Hoc Data Collection

Collect clinical outcomes, safety & vigilance, clinical experience, and usability data with ease.

Easy Study Setup

Fast and intuitive 3-step study builder. 90 seconds is all it takes!        

All Post-Market Data in One Place

Adapt forms according to different devices or product families and keep track of all post-market data on products within the same family – all in one place. No need to create projects or studies for each device.

Distribution via Email, SMS & QR-Code

Distribute each study however you prefer, you can even print a QR-code directly on your device packaging.

Automatic Subject Validation

Enjoy automatic SMS validation of subject identity to ensure full data traceability.

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See More of Our Cases Software

Get a deep dive into our Cases software and see how it can take your outcome data collection to the next level.

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500 +

MedTech Clinical Trials

Study Setup in 2-3

Weeks

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