For international healthtech companies

Enter the NHS with clinical safety built for the UK.

We help international digital health companies translate a proven product into a clinically safe, credible and deployment-ready proposition for the NHS.

A product can be successful in Europe, North America, Asia or the Middle East and still encounter unfamiliar requirements when entering the NHS. DCB0129, NHS clinical workflows, supplier assurance and deployment responsibilities all need to fit together.

Our work is led by UK doctors who have built, integrated and deployed their own software in live NHS care.

International product NHS deployment

Bridge the NHS readiness gap.

Turn your existing evidence, product knowledge and risk controls into a safety position that makes sense to UK buyers and clinical governance teams.

ProductDCB0129AssuranceDeployment
Local standard DCB0129 mapped to your product and evidence.
NHS workflow UK clinical context, users and deployment assumptions.
Supplier → NHS organisation Clear evidence and responsibilities for DCB0160.
UK doctorsDCB0129NHS softwareLive deployment
Experience across borders

Supporting UK and international health technology companies.

The NHS readiness gap

A strong product is not automatically ready for the NHS.

International teams often arrive with mature technology and credible evidence, but without the UK-specific clinical safety layer an NHS deployment requires.

The questions NHS stakeholders will ask are different.

  1. Does the product meet the DCB0129 clinical risk management standard?
  2. Who is the trained Clinical Safety Officer responsible for the safety case?
  3. Does the intended use reflect the UK clinical pathway and NHS user roles?
  4. How will the supplier safety case support the deploying organisation's DCB0160 obligations?
  5. Are integrations, operational dependencies and foreseeable misuse represented in the hazard log?
  6. How will safety be maintained through pilots, product changes and wider rollout?
What changes in the UK

You need to translate your product into NHS reality.

We help connect what you already have to the standards, language, workflows and assurance expectations used in the NHS.

01

Clinical context

Map the product to UK pathways, NHS roles, care settings and real deployment workflows.

02

DCB0129 evidence

Create a compliant, product-specific safety case rather than a generic document pack.

03

NHS assurance

Prepare for buyer, procurement and clinical governance scrutiny with clear answers and evidence.

04

Live deployment

Align supplier controls with local deployment responsibilities and post-go-live monitoring.

How we help

Practical support from first UK conversation to live NHS use.

We meet you at your current stage. Some clients need an initial readiness review; others need a complete DCB0129 safety case or ongoing named CSO support.

NHS clinical safety readiness review

A focused assessment of your current position and the work required before an NHS pilot, procurement process or deployment.

  • Review intended use, clinical claims and product workflow
  • Assess existing international safety and risk evidence
  • Identify DCB0129 gaps and NHS-specific risks
  • Produce a prioritised route to readiness

DCB0129 clinical safety case

Product-specific clinical risk management led by a trained UK Clinical Safety Officer.

Clinical Risk Management Plan Hazard workshops Hazard Log Clinical Safety Case Report Residual risk Safety sign-off

Named Clinical Safety Officer

Ongoing UK clinical safety leadership without the need to recruit a full-time in-house CSO.

  • Clinical input into product design and change
  • Hazard log and safety case maintenance
  • Support during NHS assurance and due diligence
  • Periodic review and post-market safety oversight

NHS deployment support

Help bridging the supplier's DCB0129 case and the NHS organisation's DCB0160 deployment responsibilities.

  • Clarify supplier and deployment responsibilities
  • Document assumptions and local dependencies
  • Support pilot and deployment safety discussions
  • Prepare evidence for NHS clinical governance teams
Why us

UK clinical safety advice from real doctors who built their own software in the NHS.

  • We are NHS doctors. We understand UK clinical practice, patient risk and operational workflows.
  • We are healthtech builders. We understand product teams, technical constraints, integrations and release cycles.
  • We have deployed live NHS software. Our advice reflects real assurance, integration and deployment experience.
  • We make the process usable. Your safety case should guide product decisions and provide feedback for product owners and key stakeholders.
Your route to NHS readiness

A clear path from overseas evidence to an NHS-ready safety case.

We reuse sound evidence where possible, identify what is genuinely missing, and focus effort on the clinical and deployment risks that matter.

Start with a readiness call
1

Understand your UK opportunity

We review your product, intended NHS users, target care setting, commercial stage and existing evidence.

2

Map the NHS use case

We define the UK clinical context, workflows, responsibilities, integrations and foreseeable points of failure.

3

Build the DCB0129 safety case

We lead risk analysis and create or strengthen the Clinical Risk Management Plan, Hazard Log and Safety Case Report.

4

Prepare for NHS scrutiny

We help your team respond clearly to buyers, governance leads, pilot partners and deployment organisations.

5

Support deployment and change

We maintain the safety position as the product, integrations and NHS deployments evolve.

International client FAQ

Common questions about entering the NHS.

No. Existing risk-management evidence can be valuable, but DCB0129 is an NHS clinical risk-management standard for health IT manufacturers. We assess what can be reused and what must be adapted or added for the product's NHS use.

You do not need to complete every document before your first commercial conversation. However, buyers will madate DCB0129 compliance before procurement or pilots. Leaving it too late can delay a live opportunity. An early readiness review lets you plan the work before procurement pressure builds.

Yes. We work remotely with international teams and can coordinate with product, engineering, clinical, quality, regulatory and commercial colleagues. Workshops and reviews can be arranged around practical time-zone constraints.

No. They are related parts of market and deployment readiness, but they are not interchangeable. DCB0129 concerns clinical risk management for health IT manufacturers. Medical-device regulation, DTAC, information governance, cybersecurity and procurement each have their own scope.

Yes. Where appropriate, we can provide named Clinical Safety Officer support for the initial safety case and continue on a retainer as your product enters pilots, deployment and ongoing change.
Plan your NHS entry

Speak to a UK Clinical Safety Officer.

Tell us where your company is based, what your product does and what stage you have reached with the NHS.

We will help you understand the clinical safety work required and the most sensible place to begin.