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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 Cognition Cockpit?

Cockpit Enterprise is a comprehensive software solution designed for medium to large medical device product developers, combining both requirements management and test management within a unified platform. This application is highly adaptable, allowing customization to align with the specific needs of various organizations. With its robust development environment, Cockpit Enterprise enables companies to implement their Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a controlled and auditable manner. It serves as a vital resource for manufacturers of Class II or III medical devices, facilitating the creation, review, and approval of documentation required for regulatory submissions. Best suited for established companies that already have standard operating procedures in place, Cockpit Enterprise requires sufficient resources for effective system configuration and deployment. Moreover, its user-friendly interface and built-in compliance features make it a preferred choice for businesses aiming to streamline their document management processes.

Media

Media

Integrations Supported

Act!
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

Act!
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

API Availability

Has API

API Availability

Has API

Pricing Information

€1300 per year
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
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

Cognition

Date Founded

1995

Company Location

United States

Company Website

cognition.us

Categories and Features

Application Lifecycle Management

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

Requirements Management

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

Categories and Features

Requirements Management

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

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