Related Products
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About
Are you a quality or risk manager looking for a powerful solution? With ISO2HANDLE, you gain superpowers that give you control over your quality, safety, HR, and environmental processes in no time. ISO2HANDLE is the perfect solution for businesses in virtually any industry.
Our software supports capabilities such as risk management, resource management, complaint management, task management, risk assessment, registrations, notifications, document management, audits, onboarding, evaluations, expense claims, leave requests, environmental measures, and more.
With just one click, you can generate reports, making audits a breeze.
Based in the Netherlands, we proudly support hundreds of companies worldwide.
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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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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Supported
Chromebook
Not Supported
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Audience
Businesses in virtually any industry
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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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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
$0
Free Version
Supported
Free Trial
Supported
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Pricing
No information available.
Free Version
Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Company InformationISO2HANDLE
Founded: 2015
Netherlands
www.iso2handle.nl
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Alternatives |
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Categories |
Categories |
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Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Risk Management Features
Alerts/Notifications
Supported
Auditing
Supported
Business Process Control
Supported
Compliance Management
Supported
Corrective Actions (CAPA)
Supported
Dashboard
Supported
Exceptions Management
Supported
Internal Controls Management
Supported
IT Risk Management
Supported
Legal Risk Management
Supported
Mobile Access
Supported
Operational Risk Management
Supported
Predictive Analytics
Supported
Reputation Risk Management
Supported
Response Management
Supported
Risk Assessment
Supported
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Application Lifecycle Management Features
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
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Not Supported
Automated Test Generation
Not Supported
Automated Use Case Modeling
Not Supported
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
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Integrations
Microsoft 365
Supported
ADP Workforce Now
Supported
Adyen
Supported
Asana
Supported
Basecamp
Supported
ClickUp
Supported
Confluence
Supported
FreshBooks
Supported
Google Drive
Supported
Gusto
Supported
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Integrations
Microsoft 365
Supported
ADP Workforce Now
Not Supported
Adyen
Not Supported
Asana
Not Supported
Basecamp
Not Supported
ClickUp
Not Supported
Confluence
Not Supported
FreshBooks
Not Supported
Google Drive
Not Supported
Gusto
Not Supported
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