Average Ratings 10 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

Are you in search of innovative and acknowledged strategies to enhance the management, productivity, performance, and profitability of your organization? By documenting your challenges and examining them closely, you can develop concrete and sustainable solutions systematically, leading to improved efficiency and performance. Our structured, customizable, and integrated software solutions are designed specifically for this purpose. With a focus on operational excellence, quality, compliance, and continuous improvement, we utilize the well-established "Plan - Do - Check - Act (PDCA)" methodology to ensure effective management of all activities. For over two decades, IsoVision has collaborated closely with clients to introduce new modules and features that align the software with their evolving needs. Throughout the year, we remain committed to prioritizing client feedback, integrating their requests into the software as part of our regular updates, ensuring that our solutions continuously evolve to meet the demands of the market. This dedication to our clients fosters a partnership that enhances both their operational success and our software’s capabilities.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

GitHub
Google Drive
Jira
Microsoft 365

Integrations

GitHub
Google Drive
Jira
Microsoft 365

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
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Vendor Details

Company Name

IsoVision

Founded

2000

Country

Canada

Website

www.isovision.com

Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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