Average Ratings 13 Ratings
Average Ratings 387 Ratings
Description
Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, 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 configured later.
Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster.
Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires.
With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.
Description
Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.
API Access
Has API
No
API Access
Has API
No
Integrations
GitHub
Yes
Jira
Yes
Akitra Andromeda
No
Ansys medini analyze
No
Azure DevOps Server
No
Cameo Enterprise Architecture
No
Digital.ai Agility
No
Jira Work Management
No
Kivo
No
Microsoft 365
Yes
Integrations
GitHub
Yes
Jira
Yes
Akitra Andromeda
Yes
Ansys medini analyze
Yes
Azure DevOps Server
Yes
Cameo Enterprise Architecture
Yes
Digital.ai Agility
Yes
Jira Work Management
Yes
Kivo
Yes
Microsoft 365
No
Pricing Details
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.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
United States
Website
greenlight.guru
Vendor Details
Company Name
Jama Software
Founded
2006
Country
United States
Website
www.jamasoftware.com/faster-requirements-management
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Application Development
Access Controls/Permissions
Yes
Code Assistance
No
Code Refactoring
No
Collaboration Tools
Yes
Compatibility Testing
No
Data Modeling
No
Debugging
No
Deployment Management
Yes
Graphical User Interface
No
Mobile Development
No
No-Code
No
Reporting/Analytics
Yes
Software Development
Yes
Source Control
No
Testing Management
No
Version Control
No
Web App Development
No
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
Yes
Project Management
Yes
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Product Lifecycle Management
Change Management
Yes
Compliance Management
Yes
Cost Tracking
No
Design Management
No
Document Management
Yes
Product Data Management
Yes
Project Management
Yes
Requirements Management
Yes
Supplier Management
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes
Test Management
Automation Integration
No
Collaboration Tools
No
Pass/Fail Results Tabulation
No
Reporting / Analytics
No
Requirements Management
Yes
Test Scheduling
No
Test Tracking
No
Time/Budget Tracking
No
