Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
In-STEP BLUE can manage corporate processes, workflows, or standards such as the German V-Modell XT or Automotive SPICE. You can tailor activities and artifacts according to your needs. The software features include project, requirements, document and resource management. You can also manage risk by modifying the version of the software from a central, multi-user Oracle database. Gantt-Charts and dashboards as well as cost planning and resource charts are all available to facilitate tracking progress. Remote access to progress data, scheduling, and other information is possible via the webapp.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Jira
Yes
Lotus Notes to Office 365
No
Microsoft 365
Yes
Microsoft Excel
No
Microsoft Project
No
Microsoft Visio
No
Microsoft Word
No
SAP Access Control
No
Salesforce
Yes
Integrations
Jira
Yes
Lotus Notes to Office 365
Yes
Microsoft 365
No
Microsoft Excel
Yes
Microsoft Project
Yes
Microsoft Visio
Yes
Microsoft Word
Yes
SAP Access Control
Yes
Salesforce
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Pricing Details
from 1990 €/per licence
https://ancillary-proxy.atarimworker.io?url=https%3A%2F%2Fwww.microtool.de%2Fen%2Fproducts%2Fin-step-blue%2Fpricing%2F
Free Trial
Yes
Free Version
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
Deployment
Web-Based
No
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
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
Orcanos
Founded
2004
Country
Israel
Website
www.orcanos.com
Vendor Details
Company Name
microTOOL
Founded
1984
Country
Germany
Website
www.microtool.de/en/products/in-step-blue/
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
Product Features
Change Management
Approval Workflow
Yes
Audit Trail
No
Automated Notifications
No
Change Calendar
No
Change Planning
Yes
Compliance Management
Yes
Prioritization
Yes
Release Management
Yes
Task Management
Yes
Tracking & Reporting
No
Training Management
No
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
Yes
Full Text Search
Yes
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
Yes
Project Management
Agile Methodologies
Yes
Budget Management
Yes
Client Portal
Yes
Collaboration Tools
Yes
Cost-to-Completion Tracking
Yes
Customizable Templates
Yes
Gantt Charts
Yes
Idea Management
Yes
Kanban Board
No
Milestone Tracking
Yes
Portfolio Management
Yes
Resource Management
Yes
Time & Expense Tracking
Yes
Traditional Methodologies
Yes
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
Resource Management
Capacity Management
Yes
Data Visualization
No
Demand Forecasting
No
Drag & Drop
No
Employee Scheduling
No
Filtered Search
No
Resource Allocation
Yes
Skills Tracking
No
Utilization Management
Yes
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
Yes
Corrective Actions (CAPA)
No
Dashboard
Yes
Exceptions Management
No
IT Risk Management
Yes
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
Yes
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
Yes
Test Management
Automation Integration
No
Collaboration Tools
Yes
Pass/Fail Results Tabulation
No
Reporting / Analytics
Yes
Requirements Management
Yes
Test Scheduling
No
Test Tracking
Yes
Time/Budget Tracking
Yes
Workflow Management
Access Controls/Permissions
Yes
Approval Process Control
Yes
Business Process Automation
No
Calendar Management
No
Compliance Tracking
Yes
Configurable Workflow
Yes
Customizable Dashboard
Yes
Document Management
Yes
Forms Management
Yes
Graphical Workflow Editor
No
Mobile Access
No
No-Code
No
Task Management
Yes
Third Party Integrations
No
Workflow Configuration
Yes