Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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 

Screenshots View All

Screenshots View All

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 

Alternatives

Modern Requirements4DevOps Reviews

Modern Requirements4DevOps

Modern Requirements

Alternatives

objectiF RPM Reviews

objectiF RPM

microTOOL
ReqView Reviews

ReqView

Eccam
Jama Connect Reviews

Jama Connect

Jama Software
ReqSuite® RM Reviews

ReqSuite® RM

OSSENO Software GmbH
Kovair ALM-PLM CoE Reviews

Kovair ALM-PLM CoE

Kovair Software