Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • Jama Connect Reviews & Ratings
    416 Ratings
    Company Website
  • Innoslate Reviews & Ratings
    98 Ratings
    Company Website
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    66 Ratings
    Company Website
  • Process Street Reviews & Ratings
    1,119 Ratings
    Company Website
  • Propel Reviews & Ratings
    215 Ratings
    Company Website
  • isoTracker Quality Management Reviews & Ratings
    19 Ratings
    Company Website
  • Epsilon3 Reviews & Ratings
    265 Ratings
    Company Website
  • Captain Compliance Reviews & Ratings
    337 Ratings
    Company Website
  • Epicor Connected Process Control Reviews & Ratings
    4 Ratings
    Company Website
  • SBS Asset Finance Reviews & Ratings
    3 Ratings
    Company Website

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.

Media

Media

Integrations Supported

Azure DevOps Server
GitLab
Apache Subversion
GitHub
Jira Align
Redmine

Integrations Supported

Azure DevOps Server
GitLab
ClickUp
Enterprise Architect
Jira
Microsoft Azure
Microsoft Excel
Microsoft Word
TestRail

API Availability

Has API

API Availability

Has API

Pricing Information

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Online 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
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management

Automated Requirements QA
Automated Test Generation
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 Lifecycle Management

Release Management
Requirements Review
Test Case Tracking
Version Control

Product Lifecycle Management

Change Management
Product Data Management
Requirements Management

Requirements Management

Automated Requirements QA
Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Popular Alternatives

ReqView Reviews & Ratings

ReqView

Eccam

Popular Alternatives

ReqView Reviews & Ratings

ReqView

Eccam
Kovair ALM-PLM CoE Reviews & Ratings

Kovair ALM-PLM CoE

Kovair Software
SILKROAD ALM Reviews & Ratings

SILKROAD ALM

NSE Technology