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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

ReqXChanger facilitates two-way traceability that adheres to the ReqIF standard, connecting requirements management systems with UML/SysML modeling platforms. This tool allows users to export requirements in ReqIF format from their RM system, transforming them into UML-compatible components within their modeling software, and also supports the reverse process, enabling the import of model information back into the requirements environment for better visualization of implementation coverage and effective impact analysis. Additionally, it monitors changes to linked requirements and highlights related model elements as “Suspect Links” for further examination, which aids in preventing potential miscommunications or design inconsistencies. By ensuring transparency throughout the process, it provides comprehensive visibility of coverage, encourages data synchronization between RM and modeling tools, and enhances the regulated migration or reuse of engineering assets, thereby simplifying compliance procedures. Moreover, ReqXChanger enhances efficiency by offering automation capabilities through CLI scripting, which streamlines routine tasks such as export, import, and synchronization processes while maximizing productivity. The comprehensive features provided by ReqXChanger ultimately contribute to a more cohesive and organized approach to managing both requirements and models.

Description

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools. The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities. Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Apache Subversion No 
Azure DevOps Server No 
Enterprise Architect Yes 
GitHub No 
GitLab No 
IBM Cloud Yes 
IBM DOORS Next Yes 
IBM Rhapsody Yes 
Jira Align No 
Redmine No 

Integrations

Apache Subversion Yes 
Azure DevOps Server Yes 
Enterprise Architect No 
GitHub Yes 
GitLab Yes 
IBM Cloud No 
IBM DOORS Next No 
IBM Rhapsody No 
Jira Align Yes 
Redmine Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

SodiusWillert

Country

United States

Website

www.sodiuswillert.com/en/products/reqxchanger

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management No 
Collaboration No 
History Tracking No 
Prioritization No 
Reporting No 
Status Reporting No 
Status Tracking No 
Summary Reports No 
Task Management No 
To-Do List No 
Traceability No 
User Defined Attributes No 

Product Features

Application Lifecycle Management

Administrator Level Control Yes 
Defect Tracking Yes 
Iteration Planning No 
Project Management No 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA Yes 
Automated Test Generation Yes 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

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