NEXUS

Welcome to CURISTICA Hazard Log Visualiser

A cloud-based platform for managing medical device hazard logs in compliance with DCB0129, DCB0160, and ISO 14971.

📖 Complete User Manual Available!

For detailed step-by-step instructions, workflows, and troubleshooting, see: USER_GUIDE.md

The guide covers everything from importing data to exporting regulatory reports.

🚀 Quick Start

First Time Users:

Select a product from the dropdown in the header above
Explore the tabs below to view your hazard log in different formats
Import new data via the Import tab (Excel → Database)

📤 Need to import your hazard log?

Go to the Import tab → Select Excel file → Normalize → Convert → Upload to Database

📑 Platform Tabs

2️⃣ Hazard Log

Your main workspace • View, Edit, Export • Database persistence

What is this tab for?

View: Hierarchical display with search, statistics, and pagination

Edit: Click ✏️ EDIT MODE in the floating sidebar to add/modify/delete items

Save: Click 💾 Save Changes to write to database (all users see changes)

Export: Download JSON or Excel (Data format for analysis, Report format for presentations)

Protection: Auto-save every 30 seconds • Undo/Redo (Ctrl+Z/Y) • Warning on page close

3️⃣ Bow-Tie Diagram

Simple visual: Causes → Controls → Hazard → Harm • Best for presentations

4️⃣ Network Graph (D3.js)

Interactive bow-tie with zoom/pan • Risk color-coding (1-5 scale)

5️⃣ Network Graph (Cytoscape.js) ⭐

Advanced graph • Shared control detection (orange border) • Click controls to highlight

What makes this special?

Shared Control Detection: Automatically identifies controls that mitigate multiple causes (shown with orange border and count)

Interactive Highlighting: Click any control to see its relationships with golden highlights

Split Layout: Graph view (left) + Detail panel (right) for exploring complex relationships

Best For: Finding shared controls and understanding control-to-cause mappings

6️⃣ Import

Convert Excel to database • Normalize → Convert → Upload

7️⃣ Settings

Database management • View products • Delete (requires typing "DELETE")

✅ Common Workflows

Adding New Hazards/Controls

Go to Hazard Log tab
Click ✏️ EDIT MODE in the floating sidebar (right side)
Click ➕ Add buttons to add new items
Click 💾 Save Changes to write to database
Switch tabs to see changes visualized

Editing Existing Items

Enter edit mode (✏️ EDIT MODE button)
Click any field with blue dashed border to edit
Type changes and click away to save to memory
Use Ctrl+Z to undo, Ctrl+Y to redo
Click 💾 Save Changes when ready

Importing New Product

Go to Import tab
Select Excel file (.xlsx)
Click Normalize → Convert to JSON
Fill in product metadata (name, version, DCB)
Click Upload to Database
Product appears in header dropdown immediately

Exporting Reports

Go to Hazard Log tab
Click 📊 Export Excel (Report) for NHS Standard format
Or click 📊 Export Excel (Data) for flat analysis format
File downloads with 4 tabs: Summary, Hazard Log, Risk Matrix, Controls
Use Report format for regulatory submissions (DCB0129/DCB0160)

⚠️ Deleting a Product (PERMANENT)

Go to Settings tab → Click 🔄 Refresh
Find product in table, click 🗑️ Delete
Read warning carefully
Type exactly DELETE (all caps) in the input field
Press Enter or click Delete Project button

⚠️ WARNING: Permanently deletes ALL hazards, causes, controls, evidence, and relationships. Cannot be undone! Export JSON backup first.

💡 Key Features to Remember

☁️ Database Sync: Edits persist across sessions and are visible to all users instantly
👁️ Live Preview: See edits in all tabs before clicking Save Changes
↶ Undo/Redo: Full change history with Ctrl+Z (undo) and Ctrl+Y (redo)
💾 Auto-Save: Browser backup every 30 seconds (not database - click 💾 Save for that)
🎨 Risk Color Coding: 1 Green 2 Yellow 3 Orange 4 Light Red 5 Dark Red
🔗 Shared Controls: Orange border in Cytoscape graph = control protects multiple causes

📖 Need More Help?

For detailed instructions, see USER_GUIDE.md

Step-by-step workflows
Troubleshooting guide
NHS Risk Matrix explanation
Compliance requirements (DCB0129, DCB0160, ISO 14971)
Best practices and tips

✨ Ready to Start?

Select a product from the dropdown above or click the Import tab to upload your hazard log.

📥 Import JSON to Database

Upload a processed JSON file (v2.0 normalized format) to import it directly into the database.

📄

Drag & drop your JSON file here

or click to browse

Supported: .json (v2.0 normalized format)

Selected:

📤 Import Excel Hazard Log

Upload your Excel hazard log file to convert it to JSON format. Files are processed entirely in your browser - your data never leaves your computer.

📋 Select Hazard Log Format

Generic: Works with any hazard log format. Automatically detects column structure.

📁

Drag & drop your Excel file here

or click to browse

Supported: .xlsx, .xls

📋 Product Metadata (Optional)

Add metadata about your product to be included in the JSON file.

Project Name

Project Description

Version

Date

Defaults to today if left empty

DCB Classification

Comments

➕ Add Controls to Existing Product

Upload an Excel file with additional controls to add to an existing product in the database.

Select Target Product

📁

Drag & drop your controls Excel file here

or click to browse

Supported: .xlsx, .xls

📋 Expected Excel Format

Your Excel file should contain the following columns:

cause_id - ID of the cause this control mitigates (must exist in product)
control_id - Unique identifier for the control
control_description - Description of what the control does
control_type - Type (e.g., DESIGN, TRAINING, PROCESS)
control_category - Category (e.g., initial, additional)
evidence (optional) - Supporting evidence reference

📄 Upload SPID/SCID Documents

Upload Structured Product Information Documents (SPID) or Structured Context Information Documents (SCID) in JSON format.

Link to Product (Required)

SPID: All products | SCID: DCB 0160 products only

📋 Upload SPID

Structured Product Information Document (JSON format)

📄

Drag & drop SPID JSON here

or click to browse

Supported: .json (validated against SPID schema)

Selected:

🏥 Upload SCID

Structured Context Information Document (JSON format)

📄

Drag & drop SCID JSON here

or click to browse

Supported: .json (validated against SCID schema)

Selected:

ℹ️ Document Requirements

SPID: Required for all products (DCB 0129 and DCB 0160)
SCID: Required only for DCB 0160 products (deployment context)
Documents must be valid JSON matching the SPID/SCID schema
Each product can have one SPID and multiple SCIDs
Validation is performed automatically before upload

Please select a JSON file to view

⋮⋮ 📝 Edit Controls

No cards available

Jump to Card: 0%

📋 No Hazard Log Data

Load a hazard log to start reviewing controls in Workshop mode.

Select Hazard:

⚠️

Selected:

No selection

Please select a JSON file to view

Detail View

Click on a node or edge to view details

Select Hazard:

Please select a JSON file to view

Select Hazard:

Please select a JSON file to view

Select Hazard:

Please select a JSON file to view

Detail View

Click on a node or edge to view details

Data Analyser

Load a hazard log file to see detailed statistics.

Details

Click on a statistic to view details

Export Options

Export your hazard log data in various formats. Customize filenames or use defaults with timestamp.

📄 JSON Export

Export complete hazard log data in JSON format. Ideal for data interchange, backups, and programmatic processing.

Filename (optional):

📊 Excel Export (Data)

Flat tabular format with 29 columns. Suitable for re-importing, data analysis, and Excel manipulation.

Filename (optional):

📋 Excel Export (Report)

Formatted presentation with merged cells, color-coding, and styling. Not suitable for re-importing.

Filename (optional):

🏥 NHS Standard Export

Export in NHS DCB0129 format with 4 tabs: Cover Sheet (document control), Risk Summary (with dynamic formulas), Hazard Log (26 columns with hierarchical structure), and Risk Matrix. Compliant with NHS Digital Clinical Safety standards.

📦 Standalone Package

Self-contained HTML file for offline viewing. Perfect for sharing with customers - no server required, works in any modern browser.

✅ Customer-ready: Single HTML file (~150-200KB) • Opens offline • No installation needed

💡 Tips

Leave filename blank to use default format: hazard_log_YYYY-MM-DD
Custom filenames will automatically add the appropriate extension (.json or .xlsx)
Timestamps ensure unique filenames and prevent overwriting existing files
All exports use the currently loaded hazard log data

🗄️ DATABASE

Manage products, SPID documents, and SCID documents

📦 Products

Click "Refresh" to load products

📄 SPID Documents

Click "Refresh" to load SPID documents

📋 SCID Documents

Click "Refresh" to load SCID documents

👨‍⚕️ Clinical Safety Officers (CSO)

Manage Clinical Safety Officers responsible for hazard log oversight and product safety. CSOs are assigned to products and sign off on safety assessments.

Click "Refresh" to load Clinical Safety Officers

🔄 Convert DCB 0129 to DCB 0160

Create a new DCB 0160 product by duplicating a DCB 0129 product and filtering for TRANSFERRED status hazards only. This workflow is commonly used when transitioning hazards from DCB0129 to DCB0160 standards.

Source Product (DCB 0129) *

Refresh to load available DCB 0129 products

New Product Metadata (DCB 0160)

Product Name *

Product Description

Version *

Date

Comments

📊 Conversion Preview

ℹ️ How Conversion Works

Only hazards with STATUS = "TRANSFERRED" will be included
All causes linked to transferred hazards will be copied
All controls linked to those causes will be copied
All evidence linked to those controls will be copied
The new product will have DCB = "0160"
Original IDs will be preserved for traceability
The source product remains unchanged

🏥 Health Information Technology Log

Manage health IT products used across deployment sites (from SCID documents Section E)

📋 Select Organisation

Organisation (SCID):

📋 Health IT Products

Select an organisation and click "Load HIT Log"

ℹ️ About HIT Log

The Health Information Technology Log tracks all IT products and systems used by healthcare organisations. This data is part of the SCID (Safety Case Information Document) Section E.

View all HIT products for a selected organisation
Edit product details including DCB compliance status
Add new products to track
Export data to Excel for reporting
Track integration status with GP systems
Monitor contract end dates and procurement details

Settings

Theme

Choose between light and dark color schemes

☀️ Light Mode 🌙 Dark Mode

Color Palette

Choose a color palette optimized for color vision deficiency (red-green color blindness)

🎨 Default Colors ♿ Color-Blind Friendly

Color-blind mode uses blue-orange scale instead of green-red, with added icons for clarity

Default View

Choose which tab opens by default when loading a product

Default: Workshop tab (recommended for hazard review)

Typography

Choose your preferred font family for the entire application

Hanken Grotesk (Default)

The quick brown fox jumps over the lazy dog. 0123456789

Inter

The quick brown fox jumps over the lazy dog. 0123456789

IBM Plex Sans

The quick brown fox jumps over the lazy dog. 0123456789

System Fonts

The quick brown fox jumps over the lazy dog. 0123456789

Note: Font changes apply instantly across the entire application and are saved automatically.

Navigation Style

Choose between collapsible sidebar or classic horizontal tabs

📂 Sidebar Navigation (Collapsible) 📑 Horizontal Tabs (Classic)

💡 Sidebar navigation offers keyboard shortcuts (Ctrl+B), drag-to-resize, and pinnable tabs

⚠️ Page will reload to apply navigation style changes

Preferences

Customize ID prefixes for hazards, causes, controls, and evidence. ID format will be [PREFIX]-XXX where XXX is a 3-digit number (e.g., HAZ-001).

Hazard ID Prefix

Cause ID Prefix

Control ID Prefix

Evidence ID Prefix

Note: These preferences will be used when generating new IDs for hazards, causes, controls, and evidence. Changes will take effect immediately after saving.

IRON GIANT MODE

🔐 Admin Settings

Administrative functions for user management and audit logging

👥 User Management

Manage user accounts and product access permissions

📜 Audit Log

View system activity and compliance audit trail

User

Product

Show

📜 Version History & Rollback

Track all changes to entities and rollback to previous versions

Product *

Entity Type

Change Type

📜

Select a product to view version history

💬 Feedback Configuration

Configure where user feedback is sent

Note: User feedback submitted via the header button will be emailed to this address. Default: support@curistica.com

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About NEXUS

from Curistica.AI

Development Version

Version: Loading...

Commit: Loading...

Built: Loading...

Release Notes:

Added evidence editing with pencil icon in Hazard Viewer. Fixed CSP errors by removing iframe-based link modal. About modal version now auto-populates from package.json.

⚠️ DISCLAIMER

NEXUS Hazard Log Visualisation Platform - Development Version

Important Notice: This software is currently under active development and must be used with appropriate caution.

Authorised Users Only

NEXUS is a specialist tool designed exclusively for use by trained and registered Clinical Safety Officers (CSOs) with appropriate qualifications and experience in clinical risk management and ISO 14971/DCB0129/DCB0160 compliance frameworks.

No Reliance on Automated Outputs

All outputs, visualisations, risk calculations, and recommendations generated by NEXUS must be independently verified by a qualified Clinical Safety Officer before being used in any clinical safety case, hazard log, or regulatory submission. NEXUS is a decision-support tool and does not replace professional clinical safety expertise or judgement.

Professional Responsibility

Users remain fully responsible for:

Verification of all data, calculations, and risk assessments
Compliance with applicable standards (ISO 14971, DCB0129, DCB0160, IEC 62304)
Clinical safety decisions and documentation
Regulatory submissions and patient safety outcomes

Limitation of Liability

To the fullest extent permitted by law, Curistica excludes all liability for any loss or damage arising from use of NEXUS, including but not limited to:

Errors, inaccuracies, or omissions in data or calculations
System failures, data loss, or unavailability
Decisions made in reliance on NEXUS outputs
Any consequential, indirect, or special damages

This limitation applies whether arising in contract, tort (including negligence), breach of statutory duty, or otherwise.

Development Status

As a product in development, NEXUS may contain bugs, errors, or incomplete features. Curistica provides this software "as is" without warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, or non-infringement.

Regulatory Context

NEXUS is not a medical device under the UK Medical Devices Regulations 2002 (as amended). It is a professional tool for clinical safety management and does not directly diagnose, treat, monitor, or prevent disease.

By using NEXUS, you acknowledge that:

You are a qualified Clinical Safety Officer or working under appropriate supervision
You will independently verify all outputs before clinical use
You understand this is development software subject to change
You accept full responsibility for all clinical safety decisions
You have read and understood this disclaimer

Last updated: 16th November 2025 | Version: 1.0

Legal & Policy Documents

📄 Privacy Policy 📄 Terms and Conditions 🍪 Cookie Notice

Questions about appropriate use or clinical safety services?

📧 support@curistica.com

💬 Send Feedback

Feedback Type *

Email (optional)

Provide your email if you'd like us to follow up

Your Feedback *

Press Ctrl+Enter to submit

Add New Hazard

Hazard ID:

Hazard Category:

Hazard Title:

Hazard Description:

Potential Harm:

Date Added:

Initial Severity:

Initial Likelihood:

Residual Severity:

Residual Likelihood:

Add New Cause

Cause ID:

Cause Description:

Add New Control

Control Category:

Control ID:

Control Description:

Control Type:

Control Mechanism:

Control Responsibility:

Add Evidence

Evidence:

✏️ Edit Cause

Cause ID:

Cause:

Cause Description:

✏️ Edit Control

Control ID:

Control Description:

Control Type:

Control Mechanism:

Control Category:

Responsibility:

✏️ Edit Evidence

Evidence ID:

Evidence Description:

URL (optional):

🔗 Link Existing Cause to Hazard

Select Existing Cause:

Preview:

Select a cause to see details...

🔗 Link Existing Control to Cause

Select Existing Control:

Preview:

Select a control to see details...

Mitigation Strength (optional):

🔗 Link Existing Evidence to Control

Select Existing Evidence:

Preview:

Select evidence to see details...

Confirm Deletion

Are you sure you want to delete this item?

⚠️ Delete Project

Are you sure you want to delete this product?

This will permanently delete all associated:

Hazards
Causes
Controls
Evidence
All relationships

This action cannot be undone.

Type DELETE to confirm:

📋 Duplicate Project

Enter metadata for the duplicated project:

Project Name *

Project Description

Version *

Date *

DCB Classification *

Comments

* Required fields

🔄 Convert to DCB 0160

This will create a copy of this project configured for DCB 0160.

All hazards, causes, controls, and evidence will be copied to the new project.

Location *

This will be added to the project name: "Project Name 0160 @ [Location]"

What will be created:
• DCB: 0160
• Date: Today's date
• Description: "draft 0160 created from [source project]"

💬

🤖 Hazard Log Assistant

Assistant

Hello! I'm your Hazard Log AI Assistant. I can help you:

Search and analyze hazards, causes, and controls
Find specific evidence or documentation
Summarize risk information
Answer questions about the hazard log structure

Ask me anything about your hazard log!

➕

⚠️ Add Hazard

🔸 Add Cause

🛡️ Add Control

📋 Add Evidence

Validate Entity

AI-Generated Suggestion

Current / Editable Value

Validation Decision

✅ Validate - Approve as-is without changes

🟠 Modify & Validate - Approve with edits from right column

❌ Reject - Reject with reason (explain below)

Rejection Category:

Rejection Reason: *

Workshop Mode Help

Navigate through your hazard log one control at a time using a card-based interface. Perfect for detailed review and focused analysis of each mitigation measure.

Keyboard Shortcuts

← → Navigate cards

Home First card

End Last card

Space Next card

F11 / ESC Toggle fullscreen

Mode Buttons

Edit Mode - Enable inline editing of hazard log entries
Causal Mode - Show Cause before Hazard (cause-first layout)
Fullscreen - Expand workshop to full screen for focus

✏️ Edit Evidence

Evidence ID

Parent Control

Description *

URL (optional)

Notes

✏️ Edit Control

Control ID

Parent Cause

Description *

Type

Mechanism

Responsibility

✏️ Edit Cause

Cause ID

Parent Hazard

Cause *

Cause Description

Notes

✏️ Edit Hazard

Hazard ID

Date Added

Hazard Title *

Description

Harm / Potential Clinical Impact

Status

Initial Risk Assessment

Severity

Likelihood

Risk Score (1-5)

Justification

Residual Risk Assessment

Severity

Likelihood

Risk Score (1-5)

Justification

Notes

📊 NHS Risk Matrix

This risk matrix shows how severity and likelihood combine to determine risk scores (1-5).

✏️ Edit Health IT Product

Product Name *

Purpose *

Manufacturer

Procured By

# of Users

Procured By (Other)

DCB Compliance

Contract End Date

Integrated with GP System

Notes

* Required fields