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

Validated by scientific research, our objective solutions for monitoring drowsiness ensure that you exceed all safety requirements. Elevate your driver monitoring system to the highest standards in the industry. You can either license our innovative solution or validate your existing system against two decades of reliable data. Our technology has received commercial validation from Vale, one of the largest mining companies globally. Experience real-time management and reporting through our instant cloud-based platform. This represents a groundbreaking future, where we identify key biomarkers associated with neurological conditions while driving. You can oversee your team remotely with ease, utilizing our cloud monitoring system to analyze and report findings. User-friendly and safety-focused, Optalert stands at the forefront of the medtech industry, specializing in drowsiness and impairment detection for over 20 years. Our technologies are grounded in the principle of blepharometry, a term introduced by our founder, Dr. Murray Johns, which refers to the precise measurement of eyelid movement using sophisticated sensors or cameras. The evolution of our technology continues to advance, promising even greater innovations in the field.

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 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) No 
In Person Yes 

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Vendor Details

Company Name

Optalert

Country

Australia

Website

www.optalert.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

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