Medical Device
Compliance is Complex
We Make it Simple
Medical Device
Compliance is Complex
We Make it Simple
Turn months of paperwork into hours of prep in
one secure, AI-powered platform.
Turn months of paperwork into hours of prep in one secure, AI-powered platform.
Lightning-Fast Documentation
Prepare compliance files up to 10× faster with workflows.
Lightning-Fast Documentation
Prepare compliance files up to 10× faster with workflows.
AI-Driven Compliance Intelligence
Leverage trained AI on document creation.
AI-Driven Compliance Intelligence
Leverage trained AI on document creation.
Secure, Centralized Workspace
Every compliance document in one encrypted hub.
Secure, Centralized Workspace
Every compliance document in one encrypted hub.
On-Demand Expert Support
Get direct access to certified compliance specialists.
On-Demand Expert Support
Get direct access to certified compliance specialists.
Why Manufacturers
Choose Obodux
Why Manufacturers
Choose Obodux
Built specifically for the complex world of medical device compliance, with features that matter most to decision-makers.
AI-Powered Compliance in Hours
Generate ready-to-submit, standards-aligned documentation in record time.
AI-Powered Compliance in Hours
Generate ready-to-submit, standards-aligned documentation in record time.
AI-Powered Compliance in Hours
Generate ready-to-submit, standards-aligned documentation in record time.
Stay Globally Aligned
Real-time verification against CE and UKCA frameworks.
Stay Globally Aligned
Real-time verification against CE and UKCA frameworks.
Stay Globally Aligned
Real-time verification against CE and UKCA frameworks.
Expert Guidance Built-In
AI regulatory expertise plus certified consultants.
Expert Guidance Built-In
AI regulatory expertise plus certified consultants.
Expert Guidance Built-In
AI regulatory expertise plus certified consultants.
Perfect Accuracy
100% compliance structure and formatting precision.
Perfect Accuracy
100% compliance structure and formatting precision.
Perfect Accuracy
100% compliance structure and formatting precision.
Centralized & Secure
One workspace for every file, accessible anywhere.
Centralized & Secure
One workspace for every file, accessible anywhere.
Centralized & Secure
One workspace for every file, accessible anywhere.
Always Audit-Ready
No last-minute scramble before critical compliance inspections.
Always Audit-Ready
No last-minute scramble before critical compliance inspections.
Always Audit-Ready
No last-minute scramble before critical compliance inspections.
Inspection ready, every day
Manage all CE and UKCA compliance in one place
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Comprehensive Records
Keep every device detail documented and accessible
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Real-Time Updates
Ensure no compliance information is ever outdated.
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Full Audit Trails
Track every change, approval, and action with precision.
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Inspection-Ready
Always prepared for CE and UKCA reviews.
Dashboard
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Heart Monitor
Last edited: 2h ago
CE
2 Variants
Wearable Biosensor
Last edited: 2h ago
UKCA
2 Variants
Vital Balance Sensor
Last edited: 2h ago
CE
UKCA
2 Variants
Thermometer
Last edited: 2h ago
CE
2 Variants
Stethoscope
Last edited: 2h ago
UKCA
2 Variants
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Inspection ready, every day
Manage all CE and UKCA compliance in one place
Comprehensive Records
Keep every device detail documented and accessible
Real-Time Updates
Ensure no compliance information is ever outdated.
Full Audit Trails
Track every change, approval, and action with precision.
Inspection-Ready
Always prepared for CE and UKCA reviews.
Dashboard
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Heart Monitor
Last edited: 2h ago
CE
2 Variants
Wearable Biosensor
Last edited: 2h ago
UKCA
2 Variants
Vital Balance Sensor
Last edited: 2h ago
CE
UKCA
2 Variants
Thermometer
Last edited: 2h ago
CE
2 Variants
Stethoscope
Last edited: 2h ago
UKCA
2 Variants
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Inspection ready, every day
Manage all CE and UKCA compliance in one place
Comprehensive Records
Keep every device detail documented and accessible
Real-Time Updates
Ensure no compliance information is ever outdated.
Full Audit Trails
Track every change, approval, and action with precision.
Inspection-Ready
Always prepared for CE and UKCA reviews.
Dashboard
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Heart Monitor
Last edited: 2h ago
CE
2 Variants
Wearable Biosensor
Last edited: 2h ago
UKCA
2 Variants
Vital Balance Sensor
Last edited: 2h ago
CE
UKCA
2 Variants
Thermometer
Last edited: 2h ago
CE
2 Variants
Stethoscope
Last edited: 2h ago
UKCA
2 Variants
Blood pressure monitor
Last edited: 2h ago
CE
UKCA
2 Variants
Heart Monitor
Last edited: 2h ago
CE
2 Variants
Get products to market faster
Reduce time-to-market for new devices
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AI Powered Writing
Speed up approvals with inbuilt intelligent writing tools.
Streamlined Docs
Build required documentation as you work.
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Up-to-date compliance
Follow standards. Update documentation quickly.
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Faster Launches
Go from concept to market in record time.
Risk Management Plan
Get products to market faster
Reduce time-to-market for new devices
AI Powered Writing
Speed up approvals with inbuilt intelligent writing tools.
Streamlined Docs
Build required documentation as you work.
Up-to-date compliance
Follow standards. Update documentation quickly.
Faster Launches
Go from concept to market in record time.
Risk Management Plan
Get products to market faster
Reduce time-to-market for new devices
AI Powered Writing
Speed up approvals with inbuilt intelligent writing tools.
Streamlined Docs
Build required documentation as you work.
Up-to-date compliance
Follow standards. Update documentation quickly.
Faster Launches
Go from concept to market in record time.
Risk Management Plan
Worldwide compliance in one tool
One solution for all market requirements
Central Compliance Hub
Manage all device statuses in one place.
![](data:image/svg+xml,<svg display="block" role="presentation" viewBox="0 0 28 28" xmlns="http://www.w3.org/2000/svg"><path d="M 5.833 0 L 5.833 4.667 C 5.833 4.976 5.71 5.273 5.492 5.492 C 5.273 5.71 4.976 5.833 4.667 5.833 L 0 5.833" fill="transparent" height="5.833300000000001px" id="h57ihLl1J" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(14 14)" width="5.833300000000001px"/><path d="M 0 0 L 2.333 0 C 2.952 0 3.546 0.246 3.983 0.683 C 4.421 1.121 4.667 1.714 4.667 2.333 L 4.667 4.667" fill="transparent" height="4.66667px" id="X3cM_Ijqc" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(19.834 3.5)" width="4.666699999999999px"/><path d="M 0 1.167 L 0 0" fill="transparent" height="1.1666699999999999px" id="gX3p64dG7" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(19.834 8.167)" width="1px"/><path d="M 4.667 0 L 4.667 2.333 C 4.667 2.952 4.421 3.546 3.983 3.983 C 3.546 4.421 2.952 4.667 2.333 4.667 L 0 4.667" fill="transparent" height="4.666700000000002px" id="hAsZRJeEO" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(19.834 19.833)" width="4.666699999999999px"/><path d="M 0 4.667 L 0 2.333 C 0 1.714 0.246 1.121 0.683 0.683 C 1.121 0.246 1.714 0 2.333 0 L 4.667 0" fill="transparent" height="4.66667px" id="cRRaZNF36" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(3.5 3.5)" width="4.66667px"/><path d="M 0 0 L 0.012 0" fill="transparent" height="1px" id="NT43FLQu5" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(8.166 19.833)" width="1px"/><path d="M 4.667 4.667 L 2.333 4.667 C 1.714 4.667 1.121 4.421 0.683 3.983 C 0.246 3.546 0 2.952 0 2.333 L 0 0" fill="transparent" height="4.666700000000002px" id="WGpiDzRAj" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(3.5 19.833)" width="4.66667px"/><path d="M 4.667 0 L 1.167 0 C 0.522 0 0 0.522 0 1.167 L 0 4.667 C 0 5.311 0.522 5.833 1.167 5.833 L 4.667 5.833 C 5.311 5.833 5.833 5.311 5.833 4.667 L 5.833 1.167 C 5.833 0.522 5.311 0 4.667 0 Z" fill="transparent" height="5.833309999999999px" id="TuSokM_a6" stroke-dasharray="" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" stroke="rgb(0, 0, 0)" transform="translate(8.166 8.167)" width="5.833300000000001px"/></svg>)
Smart Label Checks
Automating compliance checks
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Global Certifications
Handle CE, UKCA, and other requirements with ease.
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Multi-Country Coverage
Stay compliant in 30+ global markets.
Worldwide compliance in one tool
One solution for all market requirements
Central Compliance Hub
Manage all device statuses in one place.
Smart Label Checks
Automating compliance checks
Global Certifications
Handle CE, UKCA, and other requirements with ease.
Multi-Country Coverage
Stay compliant in 30+ global markets.
Worldwide compliance in one tool
One solution for all market requirements
Central Compliance Hub
Manage all device statuses in one place.
Smart Label Checks
Automating compliance checks
Global Certifications
Handle CE, UKCA, and other requirements with ease.
Multi-Country Coverage
Stay compliant in 30+ global markets.
AI - Powered Writing
Intelligent, step-by-step document creation
Regulation-Trained AI
Generate documents aligned to CE and UKCA.
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Guided Templates
Follow pre-built compliance structures with ease.
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Consistent Quality
Maintain accuracy and professional formatting.
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Faster Approvals
Reduce delays with ready-to-submit documentation.
Official
Document
Overview
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
AI - Powered Writing
Intelligent, step-by-step document creation
Regulation-Trained AI
Generate documents aligned to CE and UKCA.
Guided Templates
Follow pre-built compliance structures with ease.
Consistent Quality
Maintain accuracy and professional formatting.
Faster Approvals
Reduce delays with ready-to-submit documentation.
Overview
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Official
Document
AI - Powered Writing
Intelligent, step-by-step document creation
Regulation-Trained AI
Generate documents aligned to CE and UKCA.
Guided Templates
Follow pre-built compliance structures with ease.
Consistent Quality
Maintain accuracy and professional formatting.
Faster Approvals
Reduce delays with ready-to-submit documentation.
Overview
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Device Information
Labelling
Manufacture
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Checklist
Risk Management
Clinical Evaluation
Verification and Validation
Post Market Surveillance
Report Generation
Official
Document
Early Access Awaits
Experience OBODUX
Before Anyone Else
Experience OBODUX
Before Anyone Else
Simplify medical device compliance and launch faster.
Curious About Obodux?
Curious About Obodux?
We’ve answered some common questions to help you understand
how Obodux fits into your workflow and makes compliance feel easy.
Is Obodux ready for production use?
Is Obodux compliant with medical documentation standards?
Can we collaborate as a team?
What is Obodux and who is it for?
Is Obodux secure for storing sensitive documentation?
Is Obodux ready for production use?
Is Obodux compliant with medical documentation standards?
Can we collaborate as a team?
What is Obodux and who is it for?
Is Obodux secure for storing sensitive documentation?
Is Obodux ready for production use?
Can we collaborate as a team?
What is Obodux and who is it for?
Can we use this in our ISO 13485 QMS?
Do you provide training and support for my team?
Is Obodux ready for production use?
Can we collaborate as a team?
What is Obodux and who is it for?
Can we use this in our ISO 13485 QMS?
Do you provide training and support for my team?
OBODUX is SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.
Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.
© 2025 Obodux. All rights reserved. Powered by Boris Software Ltd
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OBODUX is SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.
Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.
© 2025 Obodux. All rights reserved. Powered by Boris Software Ltd
OBODUX is SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.
Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.
© 2025 Obodux. All rights reserved. Powered by Boris Software Ltd