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
No
API Access
Has API
Yes
Integrations
Apache Subversion
No
Azure DevOps Server
No
GitHub
No
GitLab
No
Jira Align
No
Redmine
No
Integrations
Apache Subversion
Yes
Azure DevOps Server
Yes
GitHub
Yes
GitLab
Yes
Jira Align
Yes
Redmine
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
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
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
No
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
No
Status Reporting
Yes
Status Tracking
No
Summary Reports
Yes
Task Management
No
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes
Product Features
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
No
Project Management
No
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
Yes
Automated Test Generation
Yes
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes