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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 Common Controls Hub?

Streamline the process of gathering evidence to verify compliance with regulations by utilizing the largest collection of regulatory data currently accessible. The Common Controls Hub Software-as-a-Service platform provides rapid access to essential information derived from the Unified Compliance Framework. By identifying the relevant regulations, users can easily access a clear and structured overview of all applicable Common Controls organized in a systematic manner. Customize these Common Controls by selecting specific industries, market sectors, and geographical regions that align with your organization’s objectives. This approach allows you to focus your Governance, Risk, and Compliance (GRC) responsibilities on only the most critical areas necessary for compliance. You can quickly produce a gap/overlap analysis between Authority Documents, greatly reducing the demands of audits. Additionally, this platform enhances GRC processes to save time, financial resources, and other compliance-related costs. Furthermore, integrating new compliance regulation controls into your existing framework is seamless, allowing for swift adjustments to adapt to changing requirements. This method not only helps organizations uphold a strong compliance stance but also promotes operational efficiency, ensuring that adherence to regulations is both effective and manageable. Ultimately, this innovative approach empowers businesses to navigate the complexities of compliance while minimizing their resource allocation.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Archer
IBM Cloud
NAVEX ESG
Onspring
Riskonnect
ServiceNow
StandardFusion
TCT Portal

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$4,995 per year
Free Version
Free Trial Offered?

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

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Common Controls Hub

Company Location

United States

Company Website

commoncontrolshub.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

Compliance

Not specified

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