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Services · Medical software

We build medical device software.

Regulated, clinical-grade software across imaging, radiotherapy, embedded devices and clinical integration, designed, built and verified to IEC 62304 and ISO 13485, with the evidence trail to defend it on audit.

What we build

From regulated device software to the engineering that keeps it shippable.

Across medical and adjacent domains: product development, modernisation, and the foundations underneath the code.

01

Regulated device software

Class IIa and IIb medical software, from concept to submission, with the evidence trail built in.

IEC 62304ISO 13485EU MDR · FDA
02

Medical imaging

DICOM pipelines, 2D/3D viewers, segmentation and registration behind PACS and clinical tools.

DICOMITK / VTKC++ · Python
03

Radiotherapy & planning

Dose engines, plan optimisation and the contouring tools clinicians use every day.

RT-DICOMDose calc
04

Embedded & device development

Firmware and software for surgical systems and clinical-trial instruments, hardware to UI.

C / C++RTOSFirmware
05

Mobile & desktop apps

Clinician- and patient-facing applications, from data capture to connected companion apps.

iOS · AndroidDesktop
06

UI / UX revamp

Bringing ageing interfaces up to date, cleaner, faster, genuinely usable clinical workflows.

IEC 62366Usability
07

Modernisation & refactoring

Untangling legacy codebases into modular, testable architecture, without stopping delivery.

RefactorArchitecture
08

Build, test & DevOps

CI/CD and build systems, growing test coverage, and release automation that keeps regulatory pace.

CI / CDTest coverageAzure
Lifecycle

How we deliver regulated software, end to end.

A V-Model lifecycle mapped to IEC 62304, with verification artefacts traced to each design phase. The way we build it is the way we defend it on audit.

Fig. 01 · IEC 62304 lifecycle, design ↔ verification trace Brand cyan: traceability links
01

Traceability that survives audit

Every requirement traced down to the unit test that verifies it. Every defect traced back to the requirement it impacts.

02

Safety classification, baked in

Class A, B, and C handled daily. The classification drives the rigour of design, review, and verification.

03

Risk file alongside the code

ISO 14971 risk management runs in parallel with development, not bolted on at submission.

04

Your QMS, or ours

ISO 13485 QMS aligned to your processes, with templates we can share if you do not have your own.

Case Studies

Work that lives inside the clinical workflow.

Detail and references available under NDA. A representative sample.

Case 01 · Cloud & algorithms

Cloud-based medical algorithm hosting platform

Cloud-native microservice platform that hosts, executes, and scales medical image contouring algorithms for university hospitals and research groups, with full DICOM integration to hospital PACS and healthcare-grade data security.

Duration30 months
Team3 dev + 1 DM
ClientGerman MedTech
Case 02 · Long-term partnership

Ongoing development for a medical imaging platform

Feature development, DICOM adoption, security hardening, performance optimisation, diagnostics infrastructure and complex bug resolution on a mission-critical imaging and radiotherapy platform, fully compliant with the client's QMS.

Duration8+ yrs · ongoing
TeamSenior devs
ProcessIEC 62304
Case 03 · QA & DevOps

Medical software QA and DevOps

Full CI/CD platform, release pipelines, DLL/EXE signing, virtualised test environments, overnight regression suites with morning reporting, and multi-layered testing strategies, keeping EU MDR and FDA pace.

Duration8+ yrs · ongoing
Team10 specialists
CoverageEU MDR · FDA
Case 04 · IEC 62304 validation

Medical lab device software & firmware. Refactor and IEC 62304 validation

Custom-built laboratory device used in drug clinical trials. We refactored the desktop application and embedded firmware into a modular, testable architecture with dependency injection and simulation mode, and delivered the full IEC 62304 documentation package and traceability matrix.

Duration3 months
TeamDedicated
ClientNL university med ctr
Case 05 · Regulatory gap analysis

IEC 62304 gap analysis for embedded medical device firmware

Therapeutic device with embedded firmware controlling safety-critical hardware. Review of all software documentation (SRS, SyRS, SDS, architecture) against IEC 62304, static firmware review against FDA and MDR expectations, and identification of safety-relevant control logic errors.

Duration3 weeks
TeamSenior embedded C + PM
ClientPolish MedTech
Talk to us

Have a medical software project in mind?

Tell us what you are building. We will tell you whether we are the right partner, honestly, and on the first call.

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