Greenlight Guru ClinicalGreenlight Guru
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Related Products
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About
Trusted by over 1,000 medical device manufacturers, Greenlight Guru is a quality management system built for the medtech industry. The platform is architected around regulatory reality, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not added later.
Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you skip the separate validation project and go live faster.
Greenlight Guru integrates AI-powered automation to reduce manual work while maintaining the audit trail and documentation rigor your business requires.
With 15 years in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and sustain commercial success.
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About
Greenlight Guru Clinical is the only electronic data capture (EDC) system built specifically for medical device and diagnostics companies, not adapted from pharma. Designed exclusively for medtech, it combines an easy to use clinical data platform with industry leading customer service, helping teams generate reliable, compliant clinical data under FDA, EU MDR, IVDR, and ISO 14155 requirements.
Get a single, validated platform for medical device studies, including:
Electronic Data Collection and eCRF
ePRO/eCOA (electronic patient and clinician reported outcomes)
eConsent
Randomization (RTSM)
PMCF Surveys (post market clinical follow up)
Adverse Events Reporting
Open API
Used by device manufacturers and medtech CROs running clinical investigations, PMCF studies, registries, and human factors testing. Every customer gets a dedicated customer success manager with real medtech experience and a validation package included with every product update.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory
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Audience
Medical Device Manufacturers
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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PricingModules:
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.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationGreenlight Guru
Founded: 2013
United States
greenlight.guru
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Company InformationGreenlight Guru
Founded: 2013
Denmark
www.greenlight.guru/clinical-electronic-data-capture-software
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Categories |
Categories |
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Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
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Clinical Trial Management Features
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Electronic Data Capture Features
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management
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Integrations
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
GitHub
Google Drive
Jira
Medidata
Microsoft 365
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Integrations
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
GitHub
Google Drive
Jira
Medidata
Microsoft 365
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