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What is aligned elements?

Aligned offers an integrated eQMS and design control for medical device and IVD organizations. The solution is engineered to help companies satisfy international regulatory expectations in a structured and efficient way, without adding unnecessary operational burden. The software aligns with major regulatory frameworks such as ISO 13485, FDA QSMR, EU MDR, and IVDR. It is used by professional teams who need reliable oversight of quality activities, product development, and regulatory documentation throughout the full lifecycle of their products. By uniting electronic quality processes and design control in one system, Aligned enables seamless collaboration across quality assurance, regulatory affairs, research and development, and executive functions. Product requirements, design records, verification and validation evidence, risk management activities, and controlled changes are inherently connected, providing continuous traceability and defensible documentation during audits and inspections.

What is 3SL Cradle?

You have the ability to oversee your needs, epics, and user stories through a series of sprints. Each sprint can incorporate your preferred methods for requirements management, model-based systems engineering (MBSE), and test management. Additionally, you have the option to implement formal change control, configuration management, and change tracking. Cradle®, our comprehensive requirements management and systems engineering software, seamlessly integrates your entire project lifecycle into one highly scalable, multiuser solution. Whether your projects are large or small, Cradle is equipped to meet all your requirements management, model-driven, defect tracking, and test management needs. With its unmatched features, flexibility, user-friendliness, and affordability, Cradle stands out as an ideal choice for those who are new to agile methodologies, systems engineering, or requirements management. Its robust capabilities ensure that you can efficiently navigate project complexities while maintaining a streamlined workflow.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

Microsoft Excel
Microsoft Project
Microsoft Visio
Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Offered?

Pricing Information

$470.00/one-time/user
RM Desktop - $470
RM Pro - $545
SE Desktop - $625
SE Pro - $700
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS
Windows
Linux

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

3SL

Date Founded

1987

Company Location

United Kingdom

Company Website

www.threesl.com

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management

Automated Requirements QA
Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Categories and Features

Application Lifecycle Management

Defect Tracking
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
Version Control

Requirements Management

Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Alerts/Notifications
Dashboard
IT Risk Management
Response Management
Risk Assessment

Test Management

Automation Integration
Pass/Fail Results Tabulation
Reporting / Analytics
Requirements Management
Test Scheduling
Test Tracking

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