Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Your information is protected with high-level security, and all communications are encrypted for safety. We conduct regular and secure backups using advanced encryption methods. User password security is both flexible and robust. Our modern database design and web technologies ensure fast interfaces and an enhanced user experience, along with efficient reporting capabilities. Tools for user management streamline processes effectively. The interface is clean and user-friendly, allowing access through multiple browser tabs and facilitating effortless data connections. Our intuitive design ensures that users can navigate without encountering a steep learning curve. Data entry follows a logical flow, placing information exactly where you would expect to find it. You have the power to choose which modules to use and can customize the platform to meet your specific needs. Reporting content is entirely under your control, allowing you to tailor the software installation for your business requirements. It serves as a comprehensive solution for all your risk and compliance office necessities. You can easily monitor both completed and pending controls, keeping all your controls and records in a single, accessible database. We adhere to global standards in Risk Management (ISO 31000) and Compliance (ISO 19600), ensuring your organization meets industry benchmarks and best practices. This commitment to quality and accessibility makes our platform not just a tool, but a partner in your compliance journey.
Description
Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.
API Access
Has API
No
API Access
Has API
No
Integrations
Jira
No
Microsoft 365
No
Salesforce
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
CRS Certus
Country
Australia
Website
crscertus.com.au
Vendor Details
Company Name
Orcanos
Founded
2004
Country
Israel
Website
www.orcanos.com
Product Features
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No
Product Features
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
Yes
Project Management
Yes
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Audit
Alerts / Notifications
No
Audit Planning
No
Compliance Management
No
Dashboard
No
Exceptions Management
No
Forms Management
No
Issue Management
No
Mobile Access
No
Multi-Year Planning
No
Risk Assessment
No
Workflow Management
No
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No