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About

Trusted by over 1,000 medical device manufacturers, Greenlight Guru is a quality management system built for the medtech industry. The platform is architected around regulatory reality, 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 added later. Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you skip the separate validation project and go live faster. Greenlight Guru integrates AI-powered automation to reduce manual work while maintaining the audit trail and documentation rigor your business requires. With 15 years in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and sustain commercial success.

About

Scientifically validated, objective drowsiness monitoring solutions. Exceed required safety standards. Make your driver monitoring system the best in class. License our solution or validate yours against 20 years of objective data. Commercially validated by Vale, one of the world’s largest mining companies. Instant, cloud-based managing and reporting. This is the future, identifying breakthrough biomarkers for neurological conditions at the wheel. Manage your team in real-time, remotely. Interrogate and report from our cloud-based monitoring system. Simple to use, safety assured. Optalert is a pioneering medtech company that has led the drowsiness and impairment detection industry for over 20 years. All of Optalert’s technologies are based on blepharometry. This term was introduced by founder Dr. Murray Johns to define the unique study of measuring eyelid movement, captured through a sensor or camera.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory

Audience

Mining companies in need of a solution to manage their remote teams in real time

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

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 Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 4.3 / 5
ease 4.3 / 5
features 4.0 / 5
design 4.0 / 5
support 3.7 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Pros & Cons from Real Users

Pros

  • The platform is straightforward and easy to navigate. I especially like having training assignments, documents, and completion status organized in one place.
  • Easy to maneuver and operate, with a user-friendly design that makes it simple to navigate and handle. It provides a smooth, convenient experience without requiring much effort.
  • Easy to navigate and easy to use. It was really straightforward to learn how to use the product and complete what I needed to.

Cons

  • Occasionally, the login or password reset process could be smoother. Improving that experience would make the platform even easier to use.
  • The controls may take a little time to get used to.
  • Honestly, there isn't much I didn't like. It works well!

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

Optalert
Australia
www.optalert.com

Alternatives

Alternatives

Propel

Propel

Propel Software
Jama Connect

Jama Connect

Jama Software
FAID Quantum

FAID Quantum

InterDynamics
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
Wenco Mining Systems

Wenco Mining Systems

Wenco International Mining Systems

Categories

Categories

Quality Management Features

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

Integrations

GitHub
Google Drive
Jira
Microsoft 365

Integrations

GitHub
Google Drive
Jira
Microsoft 365
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Claim Greenlight Guru and update features and information
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