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Ratings and Reviews 0 Ratings
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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 ReqSuite® RM?
ReqSuite® RM, developed by OSSENO Software, is an ideal solution for forward-thinking mid-sized companies seeking a user-friendly, robust, and fully customizable requirements management tool that can be deployed rapidly. As part of the latest generation of requirements management tools, it is equipped with advanced features to facilitate the oversight of requirements, test cases, risks, standards, architectural components, and various conceptual artifacts throughout the development process. This software offers an extensive suite of tools for collaborative requirements management, encompassing tracking, analysis, approval, review, export, import, and reuse, while also allowing for personalization to suit specific organizational demands. Its user-friendly interface, straightforward installation process, and complimentary premium support ensure that businesses can implement a tailored solution swiftly. By utilizing ReqSuite® RM, companies can enhance the quality of their requirements and streamline their development processes, leading to increased efficiency and uniformity; in fact, organizations may realize savings of up to 30% in overall development effort, significantly benefiting their project timelines and resource allocation. Furthermore, the emphasis on collaboration and adaptability makes ReqSuite® RM a strategic asset for any organization aiming for continuous improvement in their development practices.
Integrations Supported
Azure DevOps Server
GitLab
Apache Subversion
ClickUp
Enterprise Architect
GitHub
Jira
Jira Align
Microsoft Azure
Microsoft Excel
Integrations Supported
Azure DevOps Server
GitLab
Apache Subversion
ClickUp
Enterprise Architect
GitHub
Jira
Jira Align
Microsoft Azure
Microsoft Excel
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
OSSENO Software GmbH
Date Founded
2014
Company Location
Germany
Company Website
www.osseno.com
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
Application Development
Access Controls/Permissions
Code Assistance
Code Refactoring
Collaboration Tools
Compatibility Testing
Data Modeling
Debugging
Deployment Management
Graphical User Interface
Mobile Development
No-Code
Reporting/Analytics
Software Development
Source Control
Testing Management
Version Control
Web App Development
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
Product Lifecycle Management
Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier Management
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