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Description

isorobot serves as an advanced software solution for business management, effectively linking individuals, processes, technology, resources, and finances to align with your organizational objectives. Leveraging our expertise, we assist you in creating streamlined and scalable systems tailored to your enterprise. This performance management software focuses on achieving sustainable excellence by emphasizing innovation, quality, efficiency, and sustainability as its core principles. The solutions are grouped by fundamental business areas and organizational maturity, providing a solid foundation for growth and scalability. There is also an enterprise version available, designed for established businesses looking to expand right from the start. At the heart of the isorobot framework lies the integration of people, processes, technology, resources, and capital, forming a comprehensive model applicable to any organization. This universal framework promotes effective information sharing across various sectors, cultures, and stages of development, fostering collaboration and growth. By prioritizing these elements, isorobot empowers organizations to navigate their unique challenges and seize new opportunities.

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 Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jira No 
Microsoft 365 No 
Qlik Data Integration Yes 
Salesforce No 

Integrations

Jira Yes 
Microsoft 365 Yes 
Qlik Data Integration No 
Salesforce Yes 

Pricing Details

$225 per user per month
isorobot provides 5 pricing models that varies according to the size of the organization and also provides solution based pricinhg models.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Deployment

Web-Based No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux Yes 
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) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

isorobot

Founded

2010

Country

United Kingdom

Website

www.isorobot.io

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management Yes 
Forms Management Yes 
Issue Management Yes 
Mobile Access No 
Multi-Year Planning Yes 
Risk Assessment Yes 
Workflow Management Yes 

Business Continuity

Backup Log Yes 
Backup Scheduling Yes 
Compression Yes 
Continuous Backup Yes 
Encryption Yes 
Incremental Backup Yes 
Local Server Options Yes 
Multiple System Support Yes 
Remote Server Options Yes 
Secure Data Storage Yes 
Web Access / Restoration Yes 

GRC

Auditing Yes 
Disaster Recovery Yes 
Environmental Compliance Yes 
IT Risk Management Yes 
Incident Management Yes 
Internal Controls Management Yes 
Operational Risk Management Yes 
Policy Management Yes 

Integrated Risk Management

Audit Management Yes 
Compliance Management Yes 
Dashboard Yes 
Disaster Recovery Yes 
IT Risk Management Yes 
Incident Management Yes 
Operational Risk Management Yes 
Risk Assessment Yes 
Safety Management Yes 
Vendor Management Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard Yes 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access No 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

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 

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