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What is ReqView?

ReqView is a leading requirements management tool designed to facilitate the management of software, hardware, and systems in accordance with established industry standards such as ISO 29148. It enhances the V-Model approach, ensuring comprehensive traceability and version control with integration options for Git and SVN. Additionally, ReqView seamlessly connects with platforms like Jira and supports ReqIF formats for efficient data handling. Getting started with ReqView is straightforward; users can quickly import existing documents and then refine their requirements, risks, and testing processes. The tool allows for customization of requirement attributes to fit specific workflows, enabling users to establish connections between related requirements, verification and validation processes, safety risks, and additional critical factors. Users can generate traceability reports in various formats, including MS Word, Excel, PDF, and HTML, making it easy to share valuable insights with stakeholders and reviewers. With ReqView, you can assess the potential impact of changes to avoid unforeseen costs, while also demonstrating that safety risks have been adequately addressed and all requirements have been satisfied. Furthermore, the tool is designed to enhance the overall quality of your product, ensuring that every aspect is meticulously managed and documented.

What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Media

Media

Integrations Supported

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

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

430.00 EUR/user/year
ReqView PRO Annual License
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Windows
Mac
Linux

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Eccam

Date Founded

2004

Company Location

Czech Republic

Company Website

www.reqview.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Task Management
To-Do List
Traceability
User Defined Attributes

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

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

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