Technology Solutions for Medical & HealthTech
Software for devices and diagnostics where the evidence trail matters as much as the result.
The industry's challenges — and how we answer them.
Documentation is reconstructed at the end
Regulated submissions need requirements traceability, design history and test evidence. On most programmes that record is assembled after the software is written, from memory and commit messages, at the point in the schedule where there is least time.
We generate the evidence as the work happens: traceable requirements, reviewed changes, and pipeline output that is part of the record rather than a separate exercise.
The dataset is small, expensive and expert-labelled
Clinical image sets are nothing like consumer training data. Positives are rare, labelling requires a specialist, and a model that looks strong on a public benchmark can be useless on the real distribution.
Transfer learning and anomaly-based approaches that work with what exists, evaluated against a clinically meaningful threshold rather than an accuracy headline.
The software in the field must be the software approved
Once a device is cleared, every unit has to be running a known, verified build. Without signing and attestation there is no way to prove that, and no way to update safely.
Secure boot with signed images, anti-rollback, and attestation so a device reports its firmware identity. Update becomes possible without losing the chain of custody.
Devices are built by teams that do not overlap
Hardware, firmware, application and clinical validation often sit in separate organisations. Integration problems surface late, at the point where changes are most expensive.
We work across the stack in one team — firmware, imaging, application and cloud — so an interface problem is a conversation rather than a change request.
Medical device firmware
Real-time embedded software for instruments and connected devices, built for verification rather than speed alone.
Imaging and diagnostics AI
Classification and detection over clinical imagery, evaluated against a threshold that means something clinically.
Connectivity and data
Secure device-to-cloud paths for devices that carry patient-adjacent data.
Verification support
Automated test suites and pipeline evidence that feed the design history file.
Building a regulated device?
Tell us where you are in the lifecycle and which standard governs it. We will tell you what evidence you will need from engineering.
Schedule consultation ↗Built to the standards this sector is audited against.
We engineer toward the standards your program is measured against, and produce the evidence its certification path depends on.
IEC 62304
Medical device software lifecycle. We work to its process expectations and produce the traceability and verification records; classification and submission remain with the manufacturer.
ISO 13485
Quality management for medical devices. We support development activities within a client QMS, contributing design and test evidence in the form it requires.
ISO 14971
Risk management. Software risk analysis and mitigation are part of the design work rather than a document produced afterwards.
IEC 62443
Security for connected medical equipment: secure boot, authenticated update and key handling appropriate to a device on a hospital network.
Need a standard that is not listed? Compliance scope is defined per engagement. Talk to an engineer →
