Compliance-by-Design Engineering for Regulated Industries

We build software where compliance is part of the architecture, not an afterthought.

Since 2017, ZenBit has delivered production-grade platforms for organisations operating in heavily regulated environments across the US, UK, and EU including NHS Digital, Johnson & Johnson, Department of Health & Social Care, Oxford University Innovation, and Medecins Sans Frontieres.

Our engineering practice is built around one principle: regulated software done right costs less, ships faster, and survives audits. We call it Compliance-by-Design.

🔸 What We Build

Complex software systems, AI platforms, and integrations for organisations where regulatory requirements, data security, and auditability are non-negotiable from day one.

🔹 Compliance & Regulatory

HIPAA · GDPR · SOC 2 · ISO 13485 · IEC 62304 · ISO 27001 · NHS DTAC · DCB0129 · DCB0160 · EU MDR · IVDR · FDA SaMD · MHRA · UKCA · PCI DSS · FCA · Cyber Essentials · NIS2 · AI Act

🔸 Regulatory Intelligence by Nomius

We develop and operate Nomius a regulatory intelligence platform that continuously monitors compliance frameworks across jurisdictions and embeds them directly into our engineering process. Our clients don't just get compliant software at launch. They stay compliant as regulations evolve.

🔹 AI & Private LLM for Regulated Environments

Private LLM deployment on-premise, VPC · Secure AI for regulated industries · Domain-specific NLP · RAG for private knowledge bases · AI governance & model explainability · Zero-trust AI architecture · Federated learning · MLOps for regulated environments

🔸 Interoperability & Integration

FHIR R4/R5 · HL7 · SMART on FHIR · DICOM · EHR/EMR connectivity · Secure data pipelines · Healthcare & financial APIs · Real-world data & post-market surveillance

🔸 How We Work

Embedded into your team not a black-box vendor. Senior engineers on every project, direct communication, and delivery you can trace from architecture decision to production deployment.

Discovery -- Architecture -- Development -- Integration -- Compliance Review -- Deployment

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