EU MDR & UKCA
Technical Files,
Made Simple
The AI workspace where medical device teams build, review and maintain their CE and UKCA technical files, with specialist support when you need it.
Turn months of paperwork into hours of prep in one secure, AI-powered platform.
Faster Documentation
Prepare technical file documents faster with guided workflows.
Faster Documentation
Prepare technical file documents faster with guided 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 regulatory specialists when you need them.
On-Demand Expert Support
Get direct access to regulatory specialists when you need them.
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-Assisted Technical Documentation
Draft standards-aligned documentation, structured for review.
AI-Assisted Technical Documentation
Draft standards-aligned documentation, structured for review.
AI-Assisted Technical Documentation
Draft standards-aligned documentation, structured for review.
EU MDR and UKCA Aligned
Structured against EU MDR and UKCA requirements.
EU MDR and UKCA Aligned
Structured against EU MDR and UKCA requirements.
EU MDR and UKCA Aligned
Structured against EU MDR and UKCA requirements.
Expert Guidance Built-In
AI assistance plus regulatory specialists when you need them.
Expert Guidance Built-In
AI assistance plus regulatory specialists when you need them.
Expert Guidance Built-In
AI assistance plus regulatory specialists when you need them.
Structured for inspection-day clarity
Structured for CE/UKCA annex-oriented documentation—with your experts in control.
Structured for inspection-day clarity
Structured for CE/UKCA annex-oriented documentation—with your experts in control.
Structured for inspection-day clarity
Structured for CE/UKCA annex-oriented documentation—with your experts in control.
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 your EU MDR and UKCA technical files 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 your EU MDR and UKCA technical files 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 your EU MDR and UKCA technical files 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
Prepare technical documentation faster
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AI Powered Writing
Speed up drafting with built-in AI 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
Prepare technical documentation faster
AI Powered Writing
Speed up drafting with built-in AI 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
Prepare technical documentation faster
AI Powered Writing
Speed up drafting with built-in AI 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
EU and UK compliance in one tool
Structured around MDR Annex II and III
Central Compliance Hub
Manage all device statuses in one place.
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Smart Label Checks
Automating compliance checks
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CE and UKCA Together
Handle CE, UKCA, and other requirements with ease.
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EU and UK Coverage
Built for EU MDR, IVDR and UKCA requirements.
EU and UK compliance in one tool
Structured around MDR Annex II and III
Central Compliance Hub
Manage all device statuses in one place.
Smart Label Checks
Automating compliance checks
CE and UKCA Together
Handle CE, UKCA, and other requirements with ease.
EU and UK Coverage
Built for EU MDR, IVDR and UKCA requirements.
EU and UK compliance in one tool
Structured around MDR Annex II and III
Central Compliance Hub
Manage all device statuses in one place.
Smart Label Checks
Automating compliance checks
CE and UKCA Together
Handle CE, UKCA, and other requirements with ease.
EU and UK Coverage
Built for EU MDR, IVDR and UKCA requirements.
AI-Powered Writing
AI-assisted drafting for every technical file section
Regulation-Trained AI
Draft documents structured for EU MDR 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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Fewer Review Cycles
Reduce rework with documentation structured for review.
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
AI-assisted drafting for every technical file section
Regulation-Trained AI
Draft documents structured for EU MDR and UKCA.
Guided Templates
Follow pre-built compliance structures with ease.
Consistent Quality
Maintain accuracy and professional formatting.
Fewer Review Cycles
Reduce rework with documentation structured for review.
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
AI-assisted drafting for every technical file section
Regulation-Trained AI
Draft documents structured for EU MDR and UKCA.
Guided Templates
Follow pre-built compliance structures with ease.
Consistent Quality
Maintain accuracy and professional formatting.
Fewer Review Cycles
Reduce rework with documentation structured for review.
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
Get Started with OBODUX
Compliance Made Simple for Med Tech Professionals
Compliance Made Simple for Med Tech Professionals
Reduce manual work, save time, and stay inspection-ready
More FAQs
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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?
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 a 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.
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© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.
Obodux is a 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.
© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.
Obodux is a 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.
© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.