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Ratings and Reviews 0 Ratings
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What is aligned elements?
We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.
Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.
Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.
What is agosense.fidelia?
Effective management of requirements is essential for the development of complex systems. In industries like automotive, rail transport, and medical technology, it is common for manufacturers and suppliers to work hand in hand to define these requirements. To enable this cooperation, a centralized database is essential. Since each partner utilizes distinct tools within their own secure environments, establishing a standardized format for sharing requirement data is crucial. Each organization has the autonomy to select the requirements management tool that best fits its operational needs. Tools that support ReqIF, such as agosense.fidelia, facilitate smooth data exchanges between companies without losing any critical information, thereby promoting effective collaboration throughout the development lifecycle. As a result, partners are able to comment on, refine, or alter an originally created document in an organized manner, ensuring that all modifications are meticulously documented and preserved. This systematic method not only improves communication but also significantly boosts the overall productivity of the development process. Moreover, it fosters a culture of transparency and shared understanding among all stakeholders involved.
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
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
agosense
Date Founded
2009
Company Location
Germany
Company Website
www.agosense.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
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