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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 Cognidox ?

Cognidox serves as a comprehensive online document management system tailored for product development in the high-tech, life sciences, and medical device sectors. Available both in the cloud and as an on-premise solution, it fosters effective product lifecycle management and enhances knowledge sharing among developers, clients, partners, and customers alike. This platform is designed to be secure and dependable, offering plug-ins for a variety of programs, including Microsoft Office, and an API that facilitates the integration of numerous processes with Cognidox. At its core, Cognidox functions as a document management system, and it features an add-on that enables the licensing and distribution of documents to third parties through a fully sandboxed website, ensuring that specific documents can be published while maintaining the security of the main storage. Additionally, one of its notable add-ons is the gBMS, or Graphical Business Management System, which utilizes Visio to map out business processes effectively. A robust business management system not only enhances clarity across operations but also contributes to streamlined workflows and improved visibility throughout the organization.

Media

Media

Integrations Supported

Microsoft 365
Salesforce
Jira

Integrations Supported

Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

£10 p/user
We have 3 packages available for hosting, Start up, Scale Up and Enterprise. The Start Up package is the core system for 10 people, if you outgrow that then there is the Scale Up package which is a 20 user minimum at £15 per user for the first 25 users then each user over that is an extra £10 till you reach 100 users after which each user is then just £8.50. For companies over the size of 40 - 50 users we recommend our enterprise package for which we will work with you to get the best fit for your organisation
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS
On-Prem
Linux

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard 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

Cognidox Ltd

Date Founded

2008

Company Location

United Kingdom

Company Website

www.cognidox.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

CAPA

Not specified

Compliance

Archiving & Retention
Audit Management
FDA Compliance
ISO Compliance
Sarbanes-Oxley Compliance
Version Control

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Forms Management
Full Text Search
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

File Sharing

Audit Trail
Collaboration
Document Management
Electronic Signature
Search
User Management
Version Control
Workflow Management

Forms Automation

Not specified

Human Resources

Not specified

Life Sciences

Not specified

Project Management

Customizable Templates
Milestone Tracking

Quality Management

Corrective and Preventive Actions (CAPA)
Document Control

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