Audience

Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability

About Orcanos

Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.

Pricing

Free Version:
Free Version available.
Free Trial:
Free Trial available.

Integrations

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Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Videos and Screen Captures

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Product Details

Platforms Supported
Cloud
Windows
Android
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
Online

Orcanos Frequently Asked Questions

Q: What kinds of users and organization types does Orcanos work with?
Q: What languages does Orcanos support in their product?
Q: What kind of support options does Orcanos offer?
Q: What other applications or services does Orcanos integrate with?
Q: Does Orcanos have a mobile app?
Q: What type of training does Orcanos provide?
Q: Does Orcanos offer a free trial?

Orcanos Product 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

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

CAPA

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

Compliance

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

Document Control

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

Quality Management

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

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling

Risk Management

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