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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.

What is Modern Requirements4DevOps?

Modern Requirements4DevOps stands out as Microsoft's recommended partner for managing requirements, elevating Azure DevOps into a comprehensive Requirements Management Tool. This integration allows teams to collaborate seamlessly on a unified platform, establishing a centralized source of truth. Requirements are conveniently housed alongside your Test Cases and Code Repositories, ensuring easy access and management. Our tool is designed to accommodate agile, waterfall, and hybrid methodologies by offering functionalities such as reviews, end-to-end traceability, reporting, elaboration, and modeling, all integrated within Azure DevOps. Additionally, our powerful requirements solution boasts a premier feature set, including project audit capabilities to enhance oversight and compliance. With these robust offerings, teams can streamline their workflows and improve project outcomes significantly.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Jira
Azure DevOps Server
Digital.ai Agility
GitHub
Jama Connect
OpsHub
Planview Hub
Planview Viz
QVscribe
Rally Software
TestRail
qTest

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Contact us for pricing
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Modern Requirements

Date Founded

1999

Company Location

Canada

Company Website

www.modernrequirements.com

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

Categories and Features

Agile Project Management Tools

Backlog Management
Feedback Management
Gantt/Timeline View
Kanban Board
Prioritization
Request Management
Resource Management
Retrospectives Management
Status Tracking
Supports Scrum
Team Management
Template Management
Workflow Management

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

Compliance

Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

DevOps

Approval Workflow
Dashboard
KPIs
Policy Management
Portfolio Management
Prioritization
Release Management
Timeline Management
Troubleshooting Reports

Requirements Management

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

Risk Management

Alerts/Notifications
Auditing
Corrective Actions (CAPA)
Dashboard
IT Risk Management
Operational Risk Management
Risk Assessment

Test Management

Automation Integration
Collaboration Tools
Pass/Fail Results Tabulation
Reporting / Analytics
Requirements Management
Test Tracking

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