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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

ReqSuite® RM (from OSSENO Software) is the right choice for innovative (mid-sized) companies that want to benefit from an easy-to-use, powerful, 100% customizable, and quickly deployable requirements management tool. It belongs to the newest generation of RM tools and therefore includes powerful features for managing requirements, test cases, risks, standards, architectural elements, and other conceptual artifacts along the development cycle. The software provides a comprehensive toolkit for collaborative requirements management, tracking, analysis, approval, review, export, import, and reuse, as well as customization of the tool to meet individual needs. Additionally, its ease of use and simple set-up, as well as free premium support means you can get a customized solution quickly running. With ReqSuite® RM, organizations increase the quality of requirements, and achieve higher efficiency, ease and standardization in their development processes. Savings up to 30% of the total development effort are possible.

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 Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Azure DevOps Server Yes 
GitLab Yes 
Apache Subversion No 
ClickUp Yes 
Enterprise Architect Yes 
GitHub No 
Jira Yes 
Jira Align No 
Microsoft Azure Yes 
Microsoft Excel Yes 
Microsoft Word Yes 
Redmine No 
TestRail Yes 

Integrations

Azure DevOps Server Yes 
GitLab Yes 
Apache Subversion Yes 
ClickUp No 
Enterprise Architect No 
GitHub Yes 
Jira No 
Jira Align Yes 
Microsoft Azure No 
Microsoft Excel No 
Microsoft Word No 
Redmine Yes 
TestRail No 

Pricing Details

No price information available.
Free Trial Yes 
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 Yes 
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) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

OSSENO Software GmbH

Founded

2014

Country

Germany

Website

www.osseno.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Application Development

Access Controls/Permissions No 
Code Assistance No 
Code Refactoring No 
Collaboration Tools No 
Compatibility Testing No 
Data Modeling No 
Debugging No 
Deployment Management No 
Graphical User Interface No 
Mobile Development No 
No-Code No 
Reporting/Analytics No 
Software Development No 
Source Control No 
Testing Management No 
Version Control No 
Web App Development No 

Application Lifecycle Management

Administrator Level Control No 
Defect Tracking No 
Iteration Planning No 
Project Management No 
Release Management Yes 
Requirements Review Yes 
Task Management No 
Test Case Tracking Yes 
User Level Management No 
Version Control Yes 

Product Lifecycle Management

Change Management Yes 
Compliance Management No 
Cost Tracking No 
Design Management No 
Document Management No 
Product Data Management Yes 
Project Management No 
Requirements Management Yes 
Supplier Management No 

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 

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 

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