Related Products
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About
BrightInsight accelerates time to market for our customers’ digital health products, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across therapeutic areas. BrightInsight replaces the need for lengthy and complicated ‘build from scratch’ implementations and instead offers a pre-built and proven digital health platform designed under a Quality Management System to support global security, privacy, and regulatory requirements. We helped Roche launch a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in 6 months in Europe, and accelerated a Top 10 Biopharma companies remote patient platform from project kickoff to commercialization in less than a year. We are experts at building and maintaining biopharma and medtech regulated digital health products, with multiple commercial launches in the last year alone.
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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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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
Global IoT platform for biopharma and medtech companies
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Audience
Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory
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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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Pricing
No information available.
Free Version
Free Trial
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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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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 InformationBrightInsight
Founded: 2017
United States
brightinsight.com
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Company InformationGreenlight Guru
Founded: 2013
United States
greenlight.guru
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Categories |
Categories |
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Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Healthcare CRM Features
Audience Targeting
Campaign Management
Marketing Automation
Medical History Records
Patient Communications
Patient Management
Physician Management
Predictive Analytics
IoT Features
Application Development
Big Data Analytics
Configuration Management
Connectivity Management
Data Collection
Data Management
Device Management
Performance Management
Prototyping
Visualization
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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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