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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

ReqView is an industry standard requirements management tool that allows SW, HW, and Systems (such as ISO 29148) to be managed in compliance with industry standards. It supports V-Model, end-to-end tracability, and version control in Git/SVN. It integrates with Jira, ReqIF and ReqIF. ReqView allows you to get started quickly. Import your documents, then elaborate on requirements, risks and tests. Customize the attributes of requirements according to your workflow. Link related requirements to verification & Validation, safety risks, and other factors. Create traceability reports in MS Word, Excel PDF or HTML formats, and share them with reviewers. Estimate the impact of changes in order to avoid unexpected costs. Prove that safety risks have been mitigated and that all requirements are met. Improve the overall quality of your product.

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Bitbucket
Eclipse Capella
Git
Google Drive
IBM DOORS Next
Jira Align
Microsoft Excel
Microsoft Word
Redmine

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Bitbucket
Eclipse Capella
Git
Google Drive
IBM DOORS Next
Jira Align
Microsoft Excel
Microsoft Word
Redmine

Pricing Details

430.00 EUR/user/year
Free Trial
Free Version

Pricing Details

€1300 per year
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Eccam

Founded

2004

Country

Czech Republic

Website

www.reqview.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product 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

Product 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

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Alternatives

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