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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 Loyal?

With more than twenty years of experience in developing technology products, our team has designed solutions that are actively used by numerous businesses in 13 countries to improve their operational efficiency. We invite you to delve into our comprehensive and powerful array of products specifically created for quality and document management, which aim to reduce operational costs, save time, simplify processes, and enhance results. Our cutting-edge platform boasts a distinctive architecture that combines multiple modules and features into one unified system, providing a seamless and engaging experience for all users. This dedication to superior design and functionality distinguishes our offerings in the industry, making them a preferred choice for organizations seeking innovative solutions. By prioritizing user needs and continuously evolving our platform, we ensure that our products remain at the forefront of technological advancements.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS

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

Online Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Loyal Solutions

Date Founded

1995

Company Location

Argentina

Company Website

www.loyal-solutions.com/en/home

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

Compliance

Environmental Compliance
ISO Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

Document Management

Collaboration Tools
Compliance Tracking
Document Assembly
Document Indexing
Electronic Signature
File Recovery
File Type Conversion
Version Control

Quality Management

Audit Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
ISO Standards Management

Risk Management

Dashboard
Internal Controls Management
Response Management
Risk Assessment

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