A UK technology leadership partner, not simply a consultancy
Keza Studio is pleased to present this proposal to support SureReach Ltd's expansion into the United Kingdom healthcare market.
Having reviewed SureReach Ltd's objectives and discussed your ambitions for entering the UK digital health ecosystem, we believe the greatest value we can provide is not simply as a technology consultancy, but as your UK technology leadership partner.
Our role will be to bridge the gap between your existing development capability and the unique technical, regulatory and operational requirements of delivering digital healthcare solutions within the NHS and wider UK healthcare sector.
This will include assessing whether any current or planned SureReach Ltd functionality may fall within the UK medical-device regulatory framework overseen by the Medicines and Healthcare products Regulatory Agency (MHRA), particularly where software or AI functionality performs, supports or influences a medical purpose.
Where this is applicable, we will help SureReach Ltd establish its initial regulatory position, understand the likely technical and engineering implications, identify the documentation and evidence that may be required, and develop a practical roadmap for progressing toward UK market readiness.
Rather than replacing your existing engineering team, we will provide the strategic technical leadership, governance and UK healthcare expertise required to ensure the platform is secure, scalable, appropriately governed and ready for successful UK deployment.
This proposal therefore outlines a phased engagement beginning with a comprehensive UK Technical & Digital Health Readiness Assessment, followed by an ongoing Fractional CTO / UK Technical Lead service to guide technology strategy, coordinate engineering delivery and support SureReach Ltd's commercial growth in the UK.
Proposal record
- Client
- SureReach Ltd
- Prepared by
- Keza Studio (Keza Studio Group Ltd)
- Author
- Francis
- Date
- August 2026
- Version
- v1.1
What this engagement is designed to achieve
- 01Successfully establish its UK technology operation.
- 02Accelerate entry into the NHS and wider UK healthcare market.
- 03Align the platform with UK regulatory, clinical-safety, information-governance and security expectations.
- 04Establish an initial MHRA / Software as a Medical Device regulatory position where applicable.
- 05Identify the technical, product and engineering implications of any applicable medical-device requirements.
- 06Improve software quality, scalability and operational resilience.
- 07Establish a mature engineering and deployment capability.
- 08Establish robust CI/CD, release-management and production-governance processes.
- 09Provide experienced UK technical leadership without the immediate need for a full-time CTO.
- 10Maximise the effectiveness of SureReach Ltd's existing development team.
- 11Establish a prioritised roadmap for progressing from the current platform to UK market readiness.
Assess first, then lead
UK Technical & Digital Health Readiness Assessment
A comprehensive review of SureReach Ltd's technology platform, engineering capability and operational readiness for the UK healthcare market.
£7,500 fixed fee
See what it coversFractional CTO / UK Technical Lead
Ongoing strategic technology leadership for SureReach Ltd's UK operations, complementing and coordinating your existing development team.
£800 per month
See what it coversBy the end of Phase 1, SureReach will know
- where the platform is today;
- where it needs to be for the UK;
- what the major technical, regulatory and operational gaps are;
- what needs to happen first;
- which activities can be undertaken by the existing development team;
- which activities require specialist external support;
- and the likely investment and delivery roadmap required.
Technical Architecture Review
Reviewed
- Overall application architecture
- Cloud infrastructure
- Hosting environment
- Data architecture
- API strategy
- Scalability
- Performance
- Reliability
- Disaster recovery capability
The review will establish whether the current architecture provides a suitable foundation for UK deployment and identify areas requiring remediation or redesign.
Where the existing development team has already undertaken infrastructure or scalability modelling, we will review and validate that work rather than unnecessarily recreating it, and extend it to address UK-specific requirements where appropriate.
Engineering Review
- Development processes
- Source-control strategy
- Code quality
- Coding standards
- Technical debt
- Test coverage
- Documentation
- Team structure
- Engineering workflows
- Technical ownership
- Release processes
- Development and production access
- Dependency management
- Change-control processes
Security Assessment
Security controls reviewed
- Identity and access management
- Infrastructure security
- Application security
- Secrets management
- Vulnerability management
- Logging and monitoring
- Backup strategy
- Security governance
- Privileged access
- Data encryption
- API security
- Production access controls
- Incident-management processes
Preparing SureReach for
- Cyber Essentials Plus
- NHS Data Security and Protection Toolkit
- NHS procurement expectations
- Appropriate penetration testing
- Security assurance expected of healthcare technology suppliers
Deployment & DevOps Assessment
- Source control and branching strategy
- Continuous Integration (CI)
- Continuous Delivery / Continuous Deployment (CD)
- Automated testing
- Release management
- Development, Test, UAT and Production environments
- Infrastructure as Code
- Configuration management
- Secrets management
- Deployment approvals and governance
- Software versioning
- Release traceability
- Rollback and recovery procedures
- Monitoring, logging and observability
- Production support processes
- Incident management
- Backup and disaster recovery
Our objective is to establish a modern DevOps capability that enables confident, repeatable and auditable deployments while reducing operational risk.
This becomes particularly important if any part of the SureReach Ltd platform falls within medical-device regulation, because changes to safety-relevant software must be appropriately controlled, tested, documented and traceable.
The deployment pipeline will therefore be designed not simply for development speed, but to provide the foundations for the level of engineering governance expected within regulated healthcare environments.
UK Healthcare Readiness
- NHS interoperability requirements
- Clinical safety processes
- Applicability assessmentDCB0129
- Deployment considerationsDCB0160
- Information governance
- UK data-protection requirements
- Healthcare hosting considerations
- NHS procurement and assurance expectations
- DSP Toolkit readiness
- Cyber Essentials Plus readiness
- Accessibility considerations
- Future NHS integration opportunities
- Security governance
MHRA & Medical Device Readiness
Activities
- 01Review the platform's intended purpose, target users, clinical context and intended claims.
- 02Assess whether relevant functionality may constitute Software as a Medical Device (SaMD) and identify the likely classification direction.
- 03Review the implications of clinical decision-support, monitoring, alerting and AI functionality where applicable.
- 04Assess the current availability of supporting technical evidence, including software requirements, architecture, risk management, testing, traceability, cybersecurity, usability and change control.
- 05Identify the engineering and documentation gaps that would need to be addressed as part of any future regulatory programme.
- 06Identify where specialist medical-device regulatory support or conformity-assessment expertise will be required.
Outputs
- Draft Intended Purpose Statement
- Initial MHRA / SaMD Regulatory Readiness Assessment
- Indicative qualification / classification position
- Regulatory & Technical Documentation Gap Analysis
- Recommended regulatory and engineering roadmap
Important boundary
The objective of this phase is to establish a clear initial regulatory position and practical roadmap. It does not include formal regulatory advice, MHRA registration, conformity assessment or delivery of a complete Class IIa / Class IIb certification programme. Where these are required, they will be separately scoped with appropriately qualified specialists.
AI Governance
- AI governance
- Model management
- Model versioning
- Model change control
- Clinical risk
- Transparency
- Auditability
- Data provenance
- Human oversight
- Responsible AI practices
- Testing and validation
- Monitoring of model performance
- Potential MHRA implications where AI functionality has a medical purpose
Particular attention will be given to how changes to models are governed where those changes could affect clinical outputs.
Phase 1 Deliverables
- 01Technical Due Diligence Report
- 02Architecture Review
- 03Engineering Maturity Assessment
- 04Security Assessment
- 05Deployment Pipeline Improvement Plan
- 06UK Healthcare Readiness Assessment
- 07MHRA / Software as a Medical Device Regulatory Readiness & Gap Assessment
- 08Draft Intended Purpose & Regulatory Positioning Summary
- 09Indicative Medical Device Qualification / Classification Rationale, subject to specialist confirmation where required
- 10Regulatory & Clinical Safety Evidence / Documentation Gap Matrix
- 11MHRA / NHS Market-Readiness Roadmap
- 12Prioritised Technical Roadmap
- 13Technical & Regulatory Risk Register
- 14Recommended Delivery Plan
- 15Indicative Implementation Budget
The roadmap will set out
- what needs to happen;
- why it needs to happen;
- the recommended sequence;
- dependencies;
- responsible parties;
- which work can be delivered internally;
- which work requires Keza Studio;
- which activities require specialist regulatory or clinical expertise;
- and indicative implementation effort.
Scope Boundaries
The £7,500 Phase 1 fixed fee covers regulatory scoping, readiness assessment, gap analysis and roadmap development as described above.
The purpose of Phase 1 is to determine the appropriate regulatory direction and give SureReach Ltd a clear understanding of the work required.
It does not include delivery of an end-to-end Class IIa or Class IIb medical-device certification or conformity-assessment programme.
Where these activities are required, Keza Studio can help SureReach Ltd coordinate the programme and technical workstreams, working alongside appropriately qualified regulatory, clinical, quality and conformity-assessment specialists.
Separately scoped, not included in Phase 1
- Full medical-device technical documentation programme
- Class IIa / Class IIb conformity assessment
- Approved Body engagement and fees
- MHRA fees
- Formal regulatory / legal opinions
- Implementation and certification of an ISO 13485 Quality Management System
- Full clinical evaluation programmes
- Clinical investigations
- UK Responsible Person services
- Formal medical-device registration or regulatory submissions
- Specialist regulatory consultancy
- Independent clinical-safety services
- Specialist testing or certification
Technology Strategy
- Own and maintain the UK technology roadmap.
- Define technical strategy.
- Review architecture decisions.
- Ensure scalability.
- Support product planning.
- Guide technology investment decisions.
- Balance commercial priorities with technical delivery.
- Coordinate technical priorities arising from UK healthcare and regulatory requirements.
- Ensure that regulatory considerations are incorporated into product and technology decisions where applicable.
Engineering Leadership
- Coordinating development activities.
- Defining sprint priorities.
- Reviewing technical designs.
- Conducting architecture reviews.
- Supporting code-quality initiatives.
- Managing technical risks.
- Providing technical mentoring where appropriate.
- Establishing engineering standards.
- Improving documentation.
- Coordinating remediation work.
- Acting as the technical bridge between management and engineering.
DevOps & Platform Engineering
- CI/CD pipeline implementation and optimisation
- Automated testing strategy
- Release governance
- Infrastructure as Code
- Environment management
- Cloud architecture optimisation
- Platform monitoring and alerting
- Operational resilience
- High-availability planning
- Incident-management processes
- Release traceability
- Rollback processes
- Production-change governance
UK Healthcare Technology Leadership
Ongoing coverage
- NHS digital and technology standards
- NHS procurement readiness
- Clinical-safety processes
- DCB0129
- DSP Toolkit readiness
- Cyber Essentials Plus preparation
- Information governance
- Healthcare interoperability
- Security governance
- MHRA and medical-device considerations where applicable
- Engineering coordination
- Architecture governance
- DevOps and deployment governance
- Stakeholder engagement
- Technical reporting
- UK healthcare technology leadership
- Regulatory delivery coordination where applicable
The investment
Phase 1 · fixed fee
£7,500
UK Technical & Digital Health Readiness Assessment, delivered over 4-6 weeks, including regulatory scoping, gap analysis and the prioritised roadmap.
Phase 2 · monthly
£800per month
Fractional CTO / UK Technical Lead engagement, ongoing and periodically reviewed as SureReach Ltd's UK operation grows.
Any specialist work falling outside this engagement is quoted separately and agreed before commencement. See additional consultancy below.
Additional Consultancy
- Medical-device regulatory expertise
- Quality-management expertise
- Clinical-safety expertise
- Clinical-evidence expertise
- Cybersecurity testing
- Penetration testing
- Accessibility testing
- Interoperability expertise
- Approved Body / conformity-assessment support
Why Keza Studio
Keza Studio combines extensive software engineering leadership with practical experience delivering secure, scalable digital solutions within regulated environments.
Our focus is not simply delivering technology, it is ensuring technology supports business growth, operational excellence and successful market adoption.
For SureReach Ltd, this means bringing together technology strategy, engineering leadership, deployment maturity, UK healthcare readiness and regulatory coordination into one coherent programme.
Rather than replacing the development capability SureReach Ltd has already established, we will help strengthen it, coordinate it and provide the UK technical leadership required to navigate the next stage of the company's growth.
By acting as SureReach Ltd's UK technology leadership partner, we will help establish the governance, engineering capability, regulatory readiness and deployment maturity required to scale confidently into the UK healthcare market.
Next steps
- 01Confirm project scope, product boundaries and timelines.
- 02Schedule stakeholder and technical workshops.
- 03Conduct an intended-purpose and UK regulatory-scoping workshop.
- 04Commence the Technical & Digital Health Readiness Assessment.
- 05Review the platform, architecture, security, engineering and deployment capability.
- 06Establish the initial MHRA / medical-device regulatory position where applicable.
- 07Produce the assessment reports, MHRA/SaMD readiness outputs and strategic roadmap.
- 08Present findings and priorities to SureReach Ltd leadership.
- 09Agree any separately scoped specialist regulatory work required.
- 10Transition into the ongoing Fractional CTO / UK Technical Lead engagement.
We look forward to supporting SureReach Ltd as a long-term strategic technology partner and helping establish a successful, secure, scalable and appropriately governed presence within the UK healthcare sector.
Keza Studio (Keza Studio Group Ltd) · Francis · August 2026 · v1.1