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The Clinical Safety Operating System for:

Digital Health CompaniesNHS Organisations.AI DevelopersMedTech CompaniesClinical Safety Consultants

The SDHA Clinical Safety Operating System (CSO OS) is an AI-assisted platform that helps healthcare organisations, NHS teams, HealthTech companies and AI developers manage clinical safety throughout the lifecycle of a digital health product.

Designed by a practising UK NHS GP and qualified Clinical Safety Officer, CSO OS combines clinical governance, AI assurance and intelligent workflow automation to simplify compliance with UK clinical safety standards while reducing administrative burden.

A complimentary 45-minute conversation with Dr Jide Idowu. We'll understand your regulatory position, your product, and where SDHA can add the most value — with no commitment required.

Please, contact me via *
United States +1
Terms of Service *

Or call directly: (+44) 07376 309 553 · WhatsApp

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Request Early Access
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Build safer digital health products. Demonstrate compliance. Accelerate innovation.

Why SDHA exists.

Clinical safety has become increasingly complex.
Healthcare organisations and digital health suppliers are expected to demonstrate robust governance, maintain comprehensive documentation and comply with evolving regulatory requirements including DCB0129, DCB0160, DTAC and emerging AI assurance expectations.

Many organisations still rely on disconnected documents, spreadsheets and manual processes that make clinical safety difficult to manage and even harder to evidence.

Whether you are developing your first digital health application or managing a portfolio of AI-enabled products, CSO OS provides the tools, governance and expert support needed to build safer products with confidence.

SDHA CSO OS brings the entire clinical safety process into one intelligent platform.

Everything You Need to Manage Clinical Safety

Bridging complex compliance standards like DCB0129, DCB0160, and DTAC into a single intelligent platform.

Clinical Safety Governance

Create and manage every aspect of your clinical safety programme.

  • Clinical Safety Plans
  • Governance Frameworks
  • Clinical Risk Management
  • Safety Management Documentation
  • Project Oversight

DTAC Readiness

Prepare for NHS procurement with confidence.
Track and manage evidence across key DTAC domains including:

  • Clinical Safety
  • Data Protection
  • Technical Security
  • Interoperability
  • Usability & Accessibility

Clinical Safety Case Development

Develop structured Clinical Safety Cases with confidence. Generate and manage:

  • Clinical Safety Case Reports
  • Clinical Risk Assessments
  • Safety Justifications
  • Evidence Registers
  • Approval workflows
AI Assurance

Designed for organisations developing AI-enabled healthcare technologies.
CSO OS supports:

  • AI governance
  • Human oversight documentation
  • Explainability
  • Risk assessment
  • Evidence management
  • Assurance reporting
AI supports professional judgement—it never replaces it.

SaMD & Regulatory Support

Support for organisations developing Software as a Medical Device (SaMD).
Including:

  • SaMD classification guidance
  • Intended purpose documentation
  • Regulatory evidence management
  • Clinical evaluation support
  • MHRA pathway guidance

Hazard & Risk Management

Identify, assess and manage clinical hazards throughout the product lifecycle.
Features include:

  • Structured hazard identification
  • Risk estimation
  • Risk control management
  • Residual risk tracking
  • Review workflows
  • Audit history

Built Around the Complete Product Lifecycle

Whether you're:

  • Exploring a new idea
  • Developing an MVP
  • Preparing for DTAC
  • Deploying into the NHS
  • Managing products post-launch
CSO OS provides structured governance at every stage.

Clinical Safety Case Development

Develop structured Clinical Safety Cases with confidence. Generate and manage:

  • Clinical Safety Case Reports
  • Clinical Risk Assessments
  • Safety Justifications
  • Evidence Registers
  • Approval workflows

Built Around the Complete Product Lifecycle

Whether you're:

  • Exploring a new idea
  • Developing an MVP
  • Preparing for DTAC
  • Deploying into the NHS
  • Managing products post-launch
CSO OS provides structured governance at every stage.

AI Assurance

Designed for organisations developing AI-enabled healthcare technologies.
CSO OS supports:

  • AI governance
  • Human oversight documentation
  • Explainability
  • Risk assessment
  • Evidence management
  • Assurance reporting
AI supports professional judgement—it never replaces it.

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Designed by Clinical Safety Experts.

Why Organisations Choose SDHA CSO OS

Built by a practising UK NHS GP and qualified Clinical Safety Officer with extensive experience in digital health governance and clinical safety.
Clinical safety is built into every workflow from the beginning not added as an afterthought.
Ready for the Future
Designed to support evolving UK clinical safety standards, AI assurance frameworks and digital health governance requirements.

Who Is CSO OS For?

NHS Organisations

  • Digital Transformation Teams
  • Clinical Safety Officers
  • CCIOs
  • CNIOs
  • Innovation Teams
  • Digital Programme Leads

AI Developers

Organisations building:

  • Clinical AI
  • Decision Support Systems
  • AI Documentation Tools
  • Remote Monitoring Solutions
  • Predictive Healthcare Platforms

Digital Health Companies

  • HealthTech Start-ups
  • Scale-ups
  • Established Digital Health Suppliers
  • SaaS Providers

Independent Clinical Safety Consultants

Clinical Safety Consultants manages multiple clients and projects from one platform.

MedTech Companies

Manufacturers developing regulated software and connected medical technologies.

AI Developers

Organisations building:

  • Clinical AI
  • Decision Support Systems
  • AI Documentation Tools
  • Remote Monitoring Solutions
  • Predictive Healthcare Platforms

MedTech Companies

Manufacturers developing regulated software and connected medical technologies.

Independent Clinical Safety Consultants

Clinical Safety Consultants manages multiple clients and projects from one platform.

Traditional Clinical Safety vs SDHA CSO OS

Why Spreadsheets Are No Longer Enough.
See how CSO OS replaces fragmented manual processes with a single intelligent platform.
Traditional ApproachSDHA CSO OS
Multiple Word documentsCentralised digital workspace
Spreadsheet hazard logsStructured hazard management
Manual version controlSecure audit trail
Email approvalsBuilt-in review workflows
Static safety documentationLiving clinical safety records
Disconnected evidenceUnified evidence repository
Time-consuming administrationStreamlined digital workflows
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To get started
Ready to Transform Your Clinical Safety Process?
Discover how SDHA CSO OS can help your organisation improve clinical governance, strengthen compliance and accelerate digital innovation.

A complimentary 45-minute conversation with Dr Jide Idowu. We'll understand your regulatory position, your product, and where SDHA can add the most value — with no commitment required.

Please, contact me via *
United States +1
Terms of Service *

Or call directly: (+44) 07376 309 553 · WhatsApp

Request Early Access
Book a Personal Demo
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