Average Ratings 12 Ratings

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

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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

GURU is designed to be an easy-to-use system for installation and configuration. If you've previously installed software on your device, setting up GURU will feel equally effortless. In case you run into any challenges, don’t hesitate to seek assistance. To initiate the installation of GURU, start by downloading the GURU Console, which serves as the primary interface for the system and allows you to manage add-ins. Once you’ve successfully set up the console, you can enhance your system's capabilities by adding your desired functionalities through various add-ins. Feel free to explore the add-in library, download as many as you wish, and install them into the console, ensuring you are fully equipped and ready to use GURU! Additionally, the flexibility of GURU allows you to customize your experience continuously as new add-ins become available.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

GitHub Yes 
Google Drive Yes 
Jira Yes 
Microsoft 365 Yes 

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.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
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 No 
On-Premises No 
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 No 
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

Cedesta Systems

Founded

2007

Country

United States

Website

www.cedesta.com/products.html

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

CMMS

Asset Tracking Yes 
Calibration Management No 
Inventory Control Yes 
Key & Lock Management No 
Mobile Access Yes 
Preventive Maintenance Yes 
Purchasing Yes 
Scheduling Yes 
Service History Tracking No 
Technician Management No 
Work Order Management Yes 

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