TraceBoard Suite

TraceBoard Suite

NordTrace Solutions
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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.

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.

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

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

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

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.

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Supported
Free Trial Supported

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

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

NordTrace Solutions
Founded: 2026
Finland
traceboardsuite.com

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Categories

Categories

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

Integrations

Git Not Supported
Jira Supported
Microsoft 365 Supported
Ollama Not Supported
Salesforce Supported

Integrations

Git Supported
Jira Not Supported
Microsoft 365 Not Supported
Ollama Supported
Salesforce Not Supported
Claim Orcanos and update features and information
Claim Orcanos and update features and information
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Claim TraceBoard Suite and update features and information