aligned elementsAligned AG
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Related Products
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About
From assets to countermeasures, factoids to personas, and requirements to architectural components, enter or import a wide range of security, usability, and requirements data to find new insights ranging from interconnections between requirements and risks, to the justification behind persona characteristics. No single view captures a complex system, so automatically generate 12 different views of your emerging design from perspectives ranging from people, risks, requirements, architecture, and even physical location. Automatically generate threat models such as Data Flow Diagrams (DFDs) as your early stage design evolves. Leverage open source intelligence about potential attacks and candidate security architectures to measure your attack surface. Show all the security, usability, and design elements associated with your product's risks.
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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
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
Requirements Management solution for companies
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Audience
Medical Device Manufacturers looking for a design control management solution
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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
Free
Free Version
Free Trial
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Pricing
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version
Free Trial
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Reviews/
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Reviews/
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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 InformationCAIRIS
cairis.org
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Company InformationAligned AG
Founded: 2007
Switzerland
www.aligned.ch/
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Categories |
Categories |
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Requirements Management Features
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Application Lifecycle Management Features
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
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Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
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Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
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