aligned elementsAligned AG
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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
Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity.
The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.
Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory
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Audience
Medical Device Manufacturers looking for a design control management solution
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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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
Not Supported
Free Trial
Not Supported
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Pricing
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version
Not Supported
Free Trial
Supported
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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
Supported
Webinars
Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationGreenlight Guru
Founded: 2013
United States
greenlight.guru
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Company InformationAligned AG
Founded: 2007
Switzerland
www.aligned.ch/
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Alternatives |
Alternatives |
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Categories |
Categories |
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Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Not Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
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Application Lifecycle Management Features
Administrator Level Control
Supported
Defect Tracking
Supported
Iteration Planning
Not Supported
Project Management
Not Supported
Release Management
Supported
Requirements Review
Supported
Task Management
Supported
Test Case Tracking
Supported
User Level Management
Supported
Version Control
Supported
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Supported
Automated Test Generation
Supported
Automated Use Case Modeling
Not Supported
Change Management
Supported
Collaboration
Supported
History Tracking
Supported
Prioritization
Supported
Reporting
Supported
Status Reporting
Supported
Status Tracking
Supported
Summary Reports
Supported
Task Management
Supported
To-Do List
Supported
Traceability
Supported
User Defined Attributes
Supported
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Integrations
GitHub
Supported
Apache Subversion
Not Supported
Azure DevOps Server
Not Supported
GitLab
Not Supported
Google Drive
Supported
Jira
Supported
Jira Align
Not Supported
Microsoft 365
Supported
Redmine
Not Supported
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Integrations
GitHub
Supported
Apache Subversion
Supported
Azure DevOps Server
Supported
GitLab
Supported
Google Drive
Not Supported
Jira
Not Supported
Jira Align
Supported
Microsoft 365
Not Supported
Redmine
Supported
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