Average Ratings 13 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
Q-Med Database is ideal for small businesses striving for ISO 13485 compliance.
The Q-Med Database is an ISO 13485 compliant database to efficiently manage
corrective and preventive actions,
nonconformances,
internal audit schedules and findings,
safety improvement,
supplier corrective actions,
continual improvement projects.
Compile and analyze Customer Survey results.
Document QMS review meetings and results.
CFR21 Part 11 compliant
Cloud based or locally installed options are available. The
API Access
Has API
No
API Access
Has API
No
Integrations
GitHub
Yes
Google Drive
Yes
Jira
Yes
Microsoft 365
Yes
Sunday Business Systems
No
Integrations
GitHub
No
Google Drive
No
Jira
No
Microsoft 365
No
Sunday Business Systems
Yes
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
$1900.00/one-time
Licenses based on concurrent users
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
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
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)
No
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
No
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
United States
Website
greenlight.guru
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com/q-med-database/
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
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
No
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
No