SodiusWillert ReqXChangerSodiusWillert
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aligned elementsAligned AG
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About
ReqXChanger enables bi-directional traceability based on the ReqIF standard between requirements-management tools and UML/SysML modeling environments. It allows you to export requirements in ReqIF format from your RM tool and transform them into UML-compatible elements in your modeling tool and vice versa, importing model data back into the requirements environment to visualize implementation coverage and perform impact analysis. It detects changes to linked requirements and flags corresponding model elements with “Suspect Links” for review, helping avoid misunderstandings or design drift. Its transparency enables end-to-end coverage visibility, fosters synchronization of data between RM and modeling tools, and supports regulated migration or reuse of engineering assets while easing compliance efforts. ReqXChanger also supports automation via CLI scripting for routine export, import, and synchronization processes.
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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
Systems-engineering and software-development companies wanting a solution to maintain traceability between requirements and design models and ensure coverage, change-impact awareness and compliance
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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
No information available.
Free Version
Free Trial
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Pricing
€1300 per year
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 InformationSodiusWillert
United States
www.sodiuswillert.com/en/products/reqxchanger
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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
Enterprise Architect
GitHub
GitLab
IBM Cloud
IBM DOORS Next
IBM Rhapsody
Jira Align
Redmine
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Integrations
Apache Subversion
Azure DevOps Server
Enterprise Architect
GitHub
GitLab
IBM Cloud
IBM DOORS Next
IBM Rhapsody
Jira Align
Redmine
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