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
Requirements Portal by Altium is a requirements management and verification tool integrated directly into Altium’s solutions, including Altium Develop, Altium Agile Teams and Altium Agile Enterprise.
It enables engineering teams developing hardware products and embedded systems to create, store, and manage formalized requirements and link them to designs and verification data.
Each requirement is traceable and connected to upstream system definitions and downstream design and verification artifacts, such as schematics, PCB layouts, BOMs, and test cases, providing visibility from system design through implementation, verification, handoff, and certification.
This helps teams reduce rework, avoid misalignment across disciplines, and simplify compliance activities.
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Why choose Requirements Portal?
Unlike traditional requirements management systems that are rigid, expensive and maintained by dedicated admins, Requirements Portal offers an easy-to-use and easy-to-learn alternative that delivers a fast return on investment for engineering teams.
Compared to document-based approaches that are near-impossible to scale beyond a few hundred requirements, Requirements Portal helps you scale across complex products and multiple projects with thousands of requirements.
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Requirements Portal is the successor to Valispace, created after Altium acquired the company and integrated its technology into the Altium ecosystem.
Requirements Portal is included in Altium Develop, and the starting price includes unlimited collaborators.
API Access
Has API
No
API Access
Has API
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Pricing Details
Requirements Portal is included in Altium Develop with unlimited collaborators. Create an Altium Develop workspace for $995/year. Invite unlimited collaborators for free.
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
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
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
Altium
Founded
1985
Country
United States
Website
www.altium.com/capabilities/requirements/requirements-management
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
Product Data Management
Bill of Material Management
No
Document Management
Yes
Formula Management
No
Product Analytics
No
Product Lifecycle Management
No
Testing Management
Yes
Version Control
Yes
Product Lifecycle Management
Change Management
Yes
Compliance Management
Yes
Cost Tracking
No
Design Management
No
Document Management
Yes
Product Data Management
No
Project Management
No
Requirements Management
Yes
Supplier Management
No
Requirements Management
Automated Functional Sizing
Yes
Automated Requirements QA
Yes
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
No
To-Do List
No
Traceability
Yes
User Defined Attributes
Yes
Test Management
Automation Integration
No
Collaboration Tools
No
Pass/Fail Results Tabulation
Yes
Reporting / Analytics
Yes
Requirements Management
Yes
Test Scheduling
Yes
Test Tracking
Yes
Time/Budget Tracking
Yes