Average Ratings 12 Ratings
Average Ratings 0 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
OneGuru is an innovative AI-powered Talent Development Operating System designed to address a critical issue that many organizations overlook until it becomes a significant challenge: the inability to nurture talent that remains hidden from view.
The current landscape of talent management is highly disjointed, with skills tracked in one platform, performance metrics in another, and learning resources scattered elsewhere, resulting in a lack of cohesive integration. This disconnection leads to a reactive approach to development, limited scalability in coaching efforts, and a reliance on leaders making talent-related decisions without comprehensive insights.
OneGuru transforms this scenario.
By integrating HRIS, LMS, performance indicators, goals, and workflow data into a unified intelligence layer that monitors 44 continuous signals for each employee, it creates a holistic view of workforce capabilities. Every skill is identified through actual work performance, validated by peers, and assigned a confidence score before being utilized.
Building on this robust infrastructure is Guru, an AI-driven agent that proactively identifies significant moments, highlights potential risks and opportunities, and provides real-time coaching through established methodologies such as ICF, GROW, and Co-Active.
This seamless approach ensures that organizations can effectively harness their talent, leading to informed decision-making and strategic growth.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
GitHub
No
Google Drive
No
Jira
No
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
$21/month
Free Trial
No
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
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
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
OneGuru
Country
United States
Website
oneguru.ai/
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