Orcanos Description

Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.

Pricing

Free Version:
Yes
Free Trial:
Yes

Integrations

Reviews

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Company Details

Company:
Orcanos
Year Founded:
2004
Headquarters:
Israel
Website:
www.orcanos.com

Media

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Product Details

Platforms
Web-Based
Windows
Android App
Types of Training
Training Docs
Live Training (Online)
Webinars
In Person
Customer Support
Business Hours
Online Support

Orcanos Features and Options

Application Lifecycle Management Software

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 Software

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

Compliance Software

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Risk Management Software

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Audit Software

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Quality Management Software

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Document Control Software

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

CAPA Software

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Orcanos User Reviews

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