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

Ratings/Reviews

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Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

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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 Supported
Defect Tracking Supported
Iteration Planning Supported
Project Management Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Audit

Workflow Management Not Supported
Risk Assessment Not Supported
Exceptions Management Not Supported
Compliance Management Not Supported
Dashboard Not Supported
Issue Management Not Supported
Multi-Year Planning Not Supported
Alerts / Notifications Not Supported
Forms Management Not Supported
Audit Planning Not Supported
Mobile Access Not Supported

CAPA

Change Management Not Supported
Risk Management Not Supported
Training Management Not Supported
Nonconformance Tracking Not Supported
Quality Control Not Supported
CAPA Planning Not Supported
Incident Management Not Supported
Audit Management Not Supported
Complaint Management Not Supported
Root Cause Analysis Not Supported

Compliance

Audit Management Not Supported
Risk Management Not Supported
Controls Testing Not Supported
HIPAA Compliance Not Supported
Archiving & Retention Not Supported
FDA Compliance Not Supported
Sarbanes-Oxley Compliance Not Supported
ISO Compliance Not Supported
OSHA Compliance Not Supported
Environmental Compliance Not Supported
Version Control Not Supported
Compliance Tracking Not Supported
Incident Management Not Supported
Workflow / Process Automation Not Supported
Surveys & Feedback Not Supported
Artificial Intelligence (AI) Not Supported

Document Control

Change Management Not Supported
Escalation Management Not Supported
Periodic Review Not Supported
Compliance Management Not Supported
Archiving & Retention Not Supported
Automated Routing Not Supported
Electronic Signature Not Supported
Version Control Not Supported

Quality Management

Maintenance Management Not Supported
Risk Management Not Supported
Training Management Not Supported
ISO Standards Management Not Supported
Compliance Management Not Supported
Supplier Quality Control Not Supported
Defect Tracking Not Supported
Audit Management Not Supported
Document Control Not Supported
Corrective and Preventive Actions (CAPA) Not Supported
Complaint Management Not Supported
Equipment Management Not Supported

Requirements Management

Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported
Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported

Risk Management

Internal Controls Management Not Supported
Risk Assessment Not Supported
Compliance Management Not Supported
Corrective Actions (CAPA) Not Supported
Business Process Control Not Supported
Dashboard Not Supported
Response Management Not Supported
Auditing Not Supported
Alerts/Notifications Not Supported
Exceptions Management Not Supported
IT Risk Management Not Supported
Legal Risk Management Not Supported
Mobile Access Not Supported
Operational Risk Management Not Supported
Predictive Analytics Not Supported
Reputation Risk Management Not Supported