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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 Reqchoir?

A cloud-enabled platform tailored for product teams of varying sizes, it enhances collaboration on requirements, issues, and change management. Navigating product management involves unique challenges as it integrates diverse elements such as product vision, design, development, and sales. This function requires a common language to facilitate clear communication of requirements and priorities among different stakeholders, including executive leadership, sales, and engineering teams. Reqchoir acts as a holistic dashboard that empowers teams across functions to meet this need effectively. As a web and cloud-based tool, Reqchoir enables users to seamlessly capture and manage requirements, issues, and related workflows. With accessibility on laptops, tablets, or mobile devices, teams can improve their processes and elevate product quality through effective collaborative management, ensuring that every team member is aligned and well-informed throughout the lifecycle of the project. This approach not only simplifies the complexities inherent in product development but also fosters an environment of continuous improvement and innovation. By leveraging Reqchoir’s capabilities, teams can adapt more swiftly to changes and drive their products to success.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

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

$25.00/month
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

Alignd Labs

Date Founded

2014

Company Location

United States

Company Website

www.aligndlabs.com/product.html

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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