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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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

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

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 Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$0
Free Version Supported
Free Trial Supported

Pricing

No information available.
Free Version Supported
Free Trial Supported

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

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 Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

ISO2HANDLE
Founded: 2015
Netherlands
www.iso2handle.nl

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

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Categories

ISO Compliance Supported
Quality Management Supported
Risk Management Supported

Categories

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

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

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
Jira Not Supported
Keycloak Supported
Miro Supported
Oracle API Management Supported
PayPal Supported
QuickBooks Accountants Supported
Quickbase Supported
Workday Workforce Management Supported
Zoho Projects Supported
monday AI work platform Supported

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
Jira Supported
Keycloak Not Supported
Miro Not Supported
Oracle API Management Not Supported
PayPal Not Supported
QuickBooks Accountants Not Supported
Quickbase Not Supported
Workday Workforce Management Not Supported
Zoho Projects Not Supported
monday AI work platform Not Supported
Claim ISO2HANDLE and update features and information
Claim ISO2HANDLE and update features and information
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Claim Orcanos and update features and information