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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.

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.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Businesses in virtually any industry

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

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$0
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

ISO2HANDLE
Founded: 2015
Netherlands
www.iso2handle.nl

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

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Categories

Categories

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

Risk Management Features

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

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

Integrations

Microsoft 365
Asana
Auth0
BambooHR
ClickUp
Confluence
Google Drive
Gusto
Jira
Keycloak
Microsoft Entra ID Protection
Miro
PayPal
QuickBooks Accountants
Quickbase
Salesforce
SentinelOne Singularity
Wrike
Zoho Projects
monday AI work platform

Integrations

Microsoft 365
Asana
Auth0
BambooHR
ClickUp
Confluence
Google Drive
Gusto
Jira
Keycloak
Microsoft Entra ID Protection
Miro
PayPal
QuickBooks Accountants
Quickbase
Salesforce
SentinelOne Singularity
Wrike
Zoho Projects
monday AI work platform
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Claim ISO2HANDLE and update features and information
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