Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Managing requirements is a crucial aspect of developing intricate systems. In sectors such as automotive, rail transport, and medical technology, manufacturers and suppliers typically collaborate closely to establish these requirements. To facilitate this collaboration, a shared database is vital. Given that each partner operates with different tools within their own secure networks, a standardized format for exchanging requirement data becomes necessary. Each company has the freedom to choose the most appropriate tool for their needs in requirements management. The tools they use support ReqIF, such as agosense.fidelia, which enables seamless data exchange among the companies without any information loss, thus allowing them to collaborate effectively throughout the development process. Consequently, partners can comment on, enhance, or modify an initially created document in a structured manner, ensuring that all changes are accurately captured and retained. This organized approach not only streamlines communication but also enhances the overall efficiency of the development cycle.
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
API Access
Has API
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€1300 per year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
agosense
Founded
2009
Country
Germany
Website
www.agosense.com
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product 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
Product 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