About
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.
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About
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health.
With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems.
What Qualio delivers:
✔️ Audit ready in weeks
✔️ Inspection ready anytime — no fire drills
✔️ Faster market entry
✔️ Lower total cost of compliance
✔️ Confident, risk-managed scaling
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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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
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Audience
Small and growing businesses in Life Sciences & Healthcare
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Company InformationQualio
Founded: 2010
United States
www.qualio.com
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Alternatives |
Alternatives |
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Categories |
Categories |
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Application Lifecycle Management Features
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management Features
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Policy Management Features
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
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Integrations
Jira
Microsoft 365
Salesforce
Asana
Auth0
Azure AI Document Intelligence
Azure DevOps Server
ComplianceWire
GitHub
GitHub Advanced Security
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Integrations
Jira
Microsoft 365
Salesforce
Asana
Auth0
Azure AI Document Intelligence
Azure DevOps Server
ComplianceWire
GitHub
GitHub Advanced Security
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