TraceBoard SuiteNordTrace Solutions
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Related Products
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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.
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About
TraceBoard Suite is a self-hosted, air-gapped ready ALM platform that combines requirements traceability, compliance doc generation, and test execution into a single, secure source of truth. Running on your infrastructure via Docker, it ensures absolute data sovereignty completely offline. The suite seamlessly integrates three core modules: • TraceBoard: Connects items with cycle detection and immutable baselines. Kanban board. Features local or cloud AI integration to ingest requirements from Excel, PDF, or Word, run intelligent consistency checks, and auto-generate comprehensive audit readiness narratives. • TraceDocs: Generates compliance-ready documents (SRS, Test Plans, Design Descriptions) from frozen baselines. Markdown editor for documents with links to project requirements. • TraceTest: Test management. Logs execution evidence (screenshots, logs) and maps results back to requirements, leveraging AI to auto-generate test cases directly from source text.
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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
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Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Not Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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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
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Audience
Systems engineers, software developers, QA teams, and compliance managers building safety-critical products who need a secure, air-gapped ALM and requirements management platform with zero cloud dependency.
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Supported
Free Trial
Supported
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Pricing
€999/year/5 users
The listed license is €999 per year for five users. The vendor-submitted amount is €990 per year for five users.
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Company InformationNordTrace Solutions
Founded: 2026
Finland
traceboardsuite.com
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Alternatives |
AlternativesNo Alternatives
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Categories |
Categories |
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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
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Integrations
Git
Not Supported
Jira
Supported
Microsoft 365
Supported
Ollama
Not Supported
Salesforce
Supported
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Integrations
Git
Supported
Jira
Not Supported
Microsoft 365
Not Supported
Ollama
Supported
Salesforce
Not Supported
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