Average Ratings 13 Ratings

Total
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support

Average Ratings 0 Ratings

Total
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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

As a regulatory consultancy and technology firm, we assist businesses in adopting international standards, optimizing their internal processes, and promoting rapid expansion on a global scale. Our dedicated team of ISO consultants is equipped to offer reliable advice tailored to meet your management systems needs. With our extensive international experience and a strong background in both hardware and software sectors, we have successfully supported a diverse range of clients. Whether you need to establish a Quality Management System (QMS) with comprehensive documentation or ensure its ongoing effectiveness through efficient document management and automated workflows, we provide essential solutions customized for your unique organizational requirements, catering to both emerging enterprises and well-established businesses. Additionally, our commitment to continuous improvement means we stay updated on industry trends to further enhance your operational efficiency.

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

$250 per month
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 No 
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

Stendard

Founded

2016

Country

Singapore

Website

stendard.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

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review Yes 
Version Control Yes 

Document Generation

Batch Processing No 
Collaboration Yes 
Digital Signature No 
Interaction Tracking Yes 
Multiple Output Formats No 
Templates Yes 

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving No 
Document Assembly No 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion No 
Forms Management Yes 
Full Text Search Yes 
Offline Access No 
Optical Character Recognition Yes 
Print Management No 
Version Control Yes 

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