Clinical safety and DCB0129 support from doctors who have built NHS software.

We help healthtech companies become clinically safe, compliant, and credible for NHS deployment.

If you are building digital health software for the NHS, you will need more than a hazard log and a few template documents. You need a clinical safety process that reflects how your product really works, how clinicians will use it, and where patient risk can emerge in the real world.

Our support is led by NHS doctors who have taken their own software through clinical safety, NHS integration, live deployment, and ongoing use in the NHS.

Safety case For live NHS deployment

Not just a hazard log.

A defensible safety case connects intended use, workflow, clinical hazards, mitigations, residual risk and post go-live monitoring.

Intended use Hazards Mitigations Monitoring
Hazard log Product-specific risks, not template rows.
Clinical workflow What actually happens when the product touches care.
DCB0129 → DCB0160 Evidence aligned from supplier case to deployment responsibilities.
Doctors Clinical safety NHS software Live deployment
Companies we have worked with

Clinical safety support for Health Information Technology Companies.

About Us

We became experts in clinical safety because we had to.

Clinical Safety Officers was created after we built our own NHS software product and realised how difficult it was to find practical, clinically credible support.

"We were not looking for generic governance paperwork. We needed to understand how to make software genuinely safe. That meant working through clinical risk management, hazard identification, safety case reports, product design, deployment, and real-world operational safety." - Dr C Raj

"Over time, we developed the expertise that many digital health companies need but struggle to access: clinical safety support from people who understand both medicine and software delivery. Now we help other healthtech teams navigate the same process." - Dr R Chowdhury



01

We are doctors

Our work is led by clinicians who understand patient care, clinical workflows and the realities of NHS practice.

02

We have built NHS software

We have taken our own NHS-facing software through clinical safety, integration and live general practice use.

03

We make safety practical

We help you identify real risks, document them properly and define sensible mitigations.

04

We understand both sides

Clinical safety sits between medicine, software, operations and governance. We sit in the middle.

Beyond paperwork

Clinical safety is not just documentation.

We help you build a clinical safety case that is clear, defensible, and useful for your team and key stakeholders.

A good clinical safety process should answer practical questions:

  1. What could go wrong when this product is used in real clinical care?
  2. Which risks are created by the software, the workflow, the user, or the deployment environment?
  3. What mitigations are genuinely effective?
  4. What needs to be monitored after go-live?
  5. What evidence would reassure an NHS buyer, clinical lead, or governance team?
  6. How does the product remain safe as it changes?
Who we help

For digital health teams preparing for NHS scrutiny.

Whether you are pre-deployment, already live, or preparing for a major NHS opportunity, we can help you make your clinical safety position clearer and stronger.

A

Start-ups preparing for deployment

Support for healthtech companies moving from prototype, pilot or early product into NHS use.

B

Suppliers needing DCB0129

Practical clinical safety documentation, hazard logs, safety cases and review support.

C

Teams facing due diligence

Help responding to NHS procurement, clinical governance and assurance questions.

D

Products already live

Structured review when your product is deployed but your clinical safety position needs strengthening.

E

Teams preparing to scale

Support with integrations, pilots, procurement, change management and ongoing safety review.

F

CSO and DCB0160 support

Named Clinical Safety Officer support and help aligning supplier-side and deployment responsibilities.

What we do

Clinical safety services for NHS-facing software.

Our approach is practical and product-specific. We work with how your software actually functions, not just with generic templates.

DCB0129 clinical safety support

We help you create and maintain the core clinical safety documentation required for health IT systems.

Clinical Risk Management Plan Hazard Log Clinical Safety Case Report Risk analysis Mitigation planning Residual risk assessment Safety sign-off Ongoing maintenance

Named Clinical Safety Officer support

Retainer-based CSO support for teams that need clinical safety input throughout the year without hiring a full-time CSO.

  • Periodic safety reviews
  • Review of product changes and new features
  • Hazard log updates and clinical risk discussions
  • Support with NHS buyer questions, pilots, deployments and procurement

Clinical risk review

A structured review for products that are already built, already live, or about to be deployed.

  • Assess whether your current safety documentation is adequate
  • Check whether your hazard log reflects real clinical risks
  • Identify missing risks and weak mitigations
  • Clarify what needs to be fixed before procurement, pilot or scale-up

NHS readiness review

Clinical safety is only one part of being credible to NHS buyers. We review your product from a clinical, operational and governance perspective.

  • Clinical claims, workflows and deployment assumptions
  • User responsibilities, auditability and governance risks
  • Safety mitigations and buyer concerns
  • A clearer route to becoming easier for the NHS to trust
DCB0160 support

Moving from supplier-side safety into live NHS deployment?

We can help suppliers and NHS organisations understand how DCB0129 and DCB0160 interact, what evidence is needed, and how clinical safety responsibilities should be managed.

NHS organisations deploying health IT systems have responsibilities under DCB0160. This becomes especially important when a supplier-side clinical safety case moves into a real deployment environment.

We help clarify the evidence, responsibilities, assumptions and deployment-specific considerations that need to be addressed between manufacturer and deploying organisation.

Our process

A clear route from uncertainty to a defensible safety case.

We work through the product, the clinical context and the deployment environment so your safety documentation reflects real use.

Discuss your DCB0129 requirements
1

Discovery

We start by understanding your product, users, clinical context, intended use, deployment model and current safety position.

2

Risk analysis

We identify clinical hazards, foreseeable misuse, workflow risks, user risks, deployment risks and product-specific safety considerations.

3

Documentation

We help create or update your clinical safety documentation, including the hazard log, Clinical Risk Management Plan and Clinical Safety Case Report.

4

Review and sign-off

We work through residual risks, mitigations, evidence and sign-off so that your safety case is clear and defensible.

5

Ongoing support

For retained clients, we continue supporting product changes, new features, deployment questions and periodic safety reviews.

FAQ

Questions healthtech teams often ask.

If your product is health IT intended for NHS use and could affect patient care, clinical safety will become part of procurement, pilot approval, deployment or governance assurance. It is better to address it early than to retrofit it under pressure.

Yes. We provide retainer-based CSO support for teams. A named CSO is needed for DCB0129 compliance, clinical safety input across product changes, safety reviews, deployments, procurement questions and hazard log maintenance.

Yes. We can review an existing Clinical Risk Management Plan, Hazard Log, Clinical Safety Case Report or wider safety position and give practical feedback on gaps, risks and what needs to be strengthened.

No. We support start-ups, established suppliers, products already live, teams preparing for procurement or scale-up, and organisations working through DCB0160 deployment responsibilities.
Work with Clinical Safety Officers

Speak to a Clinical Safety Officer.

Whether you need a full DCB0129 safety case, a named CSO retainer, a clinical risk review, or support preparing for NHS deployment, we can help.

Tell us about your product and what stage you are at. We will help you understand what clinical safety support you need.