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
Quality Link 7 is designed with a focus on both individuals and technology, leveraging our extensive experience and established platform to assist organizations in streamlining processes, reducing costs, and ensuring regulatory compliance through an intuitive business operating solution. By utilizing our document management module, Quality Link enhances efficiency and eliminates the need for cumbersome manual paperwork, allowing for seamless storage and management of every document generated. Users can conveniently print "uncontrolled" copies of documents and engage in a variety of document-related tasks directly within the module. This strategic organization significantly cuts down on clerical work performed by quality personnel by up to 90 percent. Our software also simplifies the transition by effortlessly converting documents from your former management system without any learning curve, while easily integrating with your preferred applications. With Quality Link, you can finally eliminate the burdensome task of manual document upkeep that often necessitates ongoing supervision, empowering your team to focus on more strategic initiatives. Additionally, the user-friendly interface ensures that all staff members can navigate the system with ease, further enhancing productivity across the board.
API Access
Has API
No
API Access
Has API
No
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
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
No
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
No
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
Quality Mapping Solutions
Country
United States
Website
www.qmsonline.com
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
No
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
Yes