Services

Software development and expert support for regulated environments

From medical software development and embedded systems to regulatory compliance, consulting, project management and implementation, we provide comprehensive support across the entire development lifecycle.

CT · VOLUME 512 × 512 × 196 · DICOM
01

Medical Software Development

Medical device software is the core of what we do. We design, build and verify regulated, clinical-grade systems across imaging, radiotherapy, embedded devices and clinical integration, to IEC 62304 and ISO 13485, with the evidence trail to defend every release on audit.

We work the V-model end to end, each artefact traced to the design phase it proves. Risk management under ISO 14971 runs alongside the code, not bolted on at submission. It is how we have run mission-critical imaging and radiotherapy platforms for the same clients over eight years and more.

8 yrs+Longest-running platform EU MDR · FDACleared verification ISO 13485Quality system
IEC 62304ISO 13485ISO 14971DICOMHL7 · FHIRV-model
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02

Embedded Software Development

Firmware and on-device software for medical and industrial instruments. Board bring-up, drivers, the real-time core, control logic, sensor and actuator interfacing, and the on-device UI. Targets include surgical systems, clinical-trial instruments, point-of-care diagnostics and portable monitoring devices, as well as industrial automation and inspection equipment.

C / C++RTOSFirmware
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03

QA, Compliance & Regulatory

Verification, validation, risk management and the regulatory documentation required for medical software, plus the security and compliance work that applies more broadly. ISO 14971 risk files, IEC 62304 design history, ISO 27001 ISMS and NIS2 readiness, and the inputs to MDR technical documentation and FDA pre-market submissions. Delivered as part of an engineering engagement or as a standalone workstream supporting your in-house team.

ISO 14971ISO 27001NIS2
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04

Consulting & Project Management

Technical strategy, software architecture and programme leadership across industries. Engagements range from a short advisory review of an architecture or roadmap, through interim CTO or VP Engineering coverage, to embedded project and product leadership inside the customer organisation. Delivered by senior engineers with shipped products behind them in medical, industrial and enterprise contexts.

StrategyAgileDelivery
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05

Implementation & Integration

On-site implementation and rollout work for clinical and enterprise systems, with a focus on DACH and the EU. Our consultants embed with the customer, take ownership of the implementation cycle, and stay through go-live and the first weeks of operation. Scope covers ERP and WMS rollouts, HL7 and FHIR integration, PACS and clinical systems, EDI work, and the on-site training delivered in German or English where the operator team needs it.

PACSHL7FHIR
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