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After several years supporting a legacy clinical platform, the limitations of the existing architecture made a ground-up rebuild necessary. The system had accumulated constraints that capped its regulatory standing, blocked integration with modern healthcare infrastructure, and prevented any meaningful use of the clinical data the platform had been accumulating. I am leading the architecture and delivery of the rebuild, partnering with a specialist regulatory consultant throughout.

The rebuild addresses three objectives. First, achieving certified regulatory standing — progressing through Class I and Class IIa under IEC 62304 and the EU Medical Device Regulation, with quality management, requirements traceability, and risk management under ISO 14971 built into the development process from the outset. Second, interoperability with NHS systems, electronic health records, and patient data infrastructure as a core architectural requirement. Third, unlocking the AI and machine learning potential of the accumulated clinical data — the platform is designed to identify conditions less invasively, faster, and at significantly lower cost than existing alternatives, and that becomes possible only when the underlying data architecture is clean and well-governed.

• IEC 62304-aligned SDLC from day one, no remediation debt
• Certification pathway defined through Class I to Class IIa
• NHS and EHR interoperability as a core architectural requirement
• AI and ML pipelines enabled by governed clinical data architecture
• Regulatory consultant embedded in the delivery process throughout

• IEC 62304
• EU MDR
• Class IIa SaMD
• ISO 14971
• NHS interoperability
• Clinical AI
• Regulated software delivery

The organisation ran on a combination of a live CRM, legacy contact archives, Xero for accounting, event management, marketing tools, Zoom, and four WordPress sites — held together by spreadsheets and workarounds. Each platform had its own user model, so adding a team member meant another licence. No single team had a complete view of any relationship, project, or programme.

The replacement is a single internal platform: a set of independent services sharing a common data layer, deployed as a containerised stack with a unified DevOps surface covering deployment, environment management, automated backup, restore, and CI/CD pipeline. A canonical identity layer resolves people and organisations across all source systems. Each team — CRM, delivery, finance, marketing — works from a 360° view appropriate to their context, through a common API layer available to both applications and LLMs. Xero is integrated for invoice and billing visibility within the finance workflow. Role-based access control and append-only audit trails run throughout. Redundancy and scheduled backups are built into the infrastructure from the outset.

• Licence costs at 10–15% of previous spend; new users carry no licence implication
• 360° view across CRM, events, projects, finance, and marketing for each team
• Automated health checks and scheduled digest emails replace manual reporting
• Document signing integrated into the contracting workflow
• LLM-ready API layer for AI-assisted work across the business
• Unified deployment, backup, restore, and CI/CD across all services

• Systems integration
• SaaS consolidation
• API platform
• Xero integration
• Canonical identity
• Licence cost reduction
• LLM API
• DevOps and CI/CD
• Access control and audit