From concept to validated device — electronics, mechanics, firmware, connectivity, and the test evidence to back it up.
Medical devices fail in the gaps. Between hardware and firmware. Between the device and the cloud. Between what the requirements said and what the product actually does under load, on a low battery, at the edge of its operating range.
We work across all of those layers with a single team, so the gaps close early and cheaply instead of late and expensively.
We join device programmes at any stage: early feasibility on a new concept, taking an existing prototype to a manufacturable design, or sustaining and extending a device already in the field.
Capabilities
Work out whether it can be built, what it will cost, and what it will take.
The board the device runs on, designed for the constraints it will actually meet.
The housing, the fit, and everything the user physically touches.
The code on the device — where reliability is decided.
Getting data off the device, securely and reliably, and putting it somewhere useful.
Proving the device does what the requirements say — with documentation you can hand to your quality team.
Scope
We are an engineering partner, not a regulatory consultancy.
We work within your quality system and produce design and test documentation in the form your regulatory team needs, alongside your internal or appointed regulatory specialists. Our engineers are used to working under those constraints and to producing records that hold up to review.
If you do not yet have a quality system in place, we will say so at the start and help you plan the programme around getting one — rather than building first and discovering the gap at submission.
Devices we work on
How to work with us
We take the programme end to end, from concept through to a validated design ready for manufacture, and stay on for sustaining engineering.
A team that works as an extension of yours, on your backlog and in your tools, scaling up and down as the programme demands.
A defined piece of work with a fixed scope — a firmware module, a board redesign, a connectivity layer, a test campaign — delivered against agreed acceptance criteria.
Ongoing maintenance for a device already in the field: firmware updates, security patches, field-issue investigation and incremental capability.
Send us what you have — a concept note, a requirements document, a prototype that is not behaving. We will come back with a technical view and a straight answer on whether we are the right team for it.