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
Founded in 2004, Sunday Business Systems (SBS) specializes in providing quality management software and consulting services that help businesses comply with a range of ISO certifications like ISO 9001:2015 and ISO 13485. SBS’s product suite includes tools for document control, asset tracking, corrective actions, and preventive maintenance. Their cloud-based solutions are designed to simplify and automate key business processes, while their consulting services offer expert guidance for businesses aiming for ISO certification or requiring customized software for manufacturing or compliance needs.
API Access
Has API
No
API Access
Has API
No
Integrations
Asset Tracking Database
No
FMEA Database
No
Jira
Yes
Microsoft 365
Yes
Q-Med Database
No
SBS Ground Control
No
SBS Inspection Database
No
SBS Quality Database
No
SBS Quality Management Software
No
SBS T-Med Database
No
Integrations
Asset Tracking Database
Yes
FMEA Database
Yes
Jira
No
Microsoft 365
No
Q-Med Database
Yes
SBS Ground Control
Yes
SBS Inspection Database
Yes
SBS Quality Database
Yes
SBS Quality Management Software
Yes
SBS T-Med Database
Yes
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Pricing Details
$295
Pricing varies by product and by the number of concurrent users. See individual product pages for detailed pricing.
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
Yes
On-Premises
Yes
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
No
Vendor Details
Company Name
Orcanos
Founded
2004
Country
Israel
Website
www.orcanos.com
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com
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
Asset Tracking
Activity Tracking
Yes
Audit Trails
Yes
Barcoding / RFID
No
Checkout / Check-In
No
Depreciation Tracking
Yes
Disposal Tracking
No
Inventory Management
Yes
Location Tracking
Yes
QR Codes
No
Reservations
No
Service History
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Inspection
Appointment Management
No
Customer Database
No
Dispatch Management
No
Equipment Tracking
Yes
Photos In Reports
No
Print on Site
No
Report Templates
No
Speech Recognition
No
Subcontractor Management
No
Manufacturing
Accounting Integration
No
ERP
No
MES
No
MRP
No
Maintenance Management
Yes
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
Yes
Safety Management
Yes
Shipping Management
No
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
Vendor Management
Audit Management
Yes
Contact Management
Yes
Customer Database
Yes
Self Service Portal
No
Supplier Master Data
Yes
Transaction History
Yes
Vendor Maintained Profiles
No
Vendor Managed Inventory
No
Vendor Performance Rating
Yes
Vendor Qualification Tracking
Yes