Related Products
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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.
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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.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory
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Audience
Mining companies in need of a solution to manage their remote teams in real time
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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PricingModules:
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
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationGreenlight Guru
Founded: 2013
United States
greenlight.guru
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Company InformationOptalert
Australia
www.optalert.com
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Categories |
Categories |
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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
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Integrations
GitHub
Google Drive
Jira
Microsoft 365
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