Greenlight Guru Clinical
4.3 out of 5 starsGreenlight Guru
4.4 out of 5 starsRatings and Reviews 12 Ratings
Ratings and Reviews 14 Ratings
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What is Greenlight Guru Clinical?
Medical device and diagnostics companies running clinical studies are often stuck configuring EDC software that was built for pharmaceutical trials and never designed around FDA, EU MDR, IVDR, or ISO 14155 requirements. Greenlight Guru Clinical solves that by being the only electronic data capture (EDC) system built from the ground up for medtech, so teams aren't reworking someone else's pharma template to fit a device study.
Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence.
Get a single, validated platform covering the full lifecycle of a device or diagnostics study, including:
Electronic Data Collection and eCRF design, with GCP compliant structures and built in audit trails
ePRO/eCOA for patient and clinician reported outcomes, collected in person or remotely on any device
eConsent for compliant, auditable enrollment
Randomization (RTSM) for controlled and comparative studies
PMCF Surveys for post market clinical follow up under EU MDR
Adverse Events Reporting built into the platform
Leading-edge, open API for connecting study data to other clinical or quality systems
Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech. A validation package is included with every product update, removing the ongoing burden of software revalidation from the quality team. Every customer also gets a dedicated customer success manager with real medtech experience, not a generalist software account rep. For manufacturers already on Greenlight Guru's quality management system (QMS), Clinical extends into one connected platform spanning quality, product development, and clinical evidence.
What is Greenlight Guru?
Greenlight Guru serves more than 1,000 device manufacturers with a quality management system engineered specifically for medtech. Rather than forcing your workflow into a generic platform, the system is architected around regulatory reality. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 compliance is aligned at the core, not added as an afterthought.
Go live in weeks instead of quarters. You get 80+ pre-validated templates and medtech expert guidance, so you skip the separate validation project entirely.
Greenlight Guru integrates AI automation to reduce manual work while maintaining the audit trail and documentation rigor your business demands.
With 15 years specializing in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and build lasting commercial success.
Integrations Supported
BSI CTMS
ChatGPT
Claude
Claude Duet
Claude for Legal
Cursor
Gemini
API Availability
Has API
API Availability
Pricing Information
Pricing not provided
Free Trial Offered?
Pricing Information
Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
Denmark
Company Website
www.greenlight.guru/clinical-electronic-data-capture-software
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
United States
Company Website
greenlight.guru
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Scheduling
Study Planning
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management
Categories and Features
Electronic Batch Records (EBR)
Not specified
Medical Quality Management Systems
Not specified
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management