In healthcare the engineering is rarely the hard part. The hard part is that every decision has to be justifiable to somebody who was not in the room, years later, in a format an assessor accepts. Design history, traceability from requirement to test, and change control are not overhead here; they are the deliverable alongside the product.
What constrains the engineering here
Traceability, end to end
Every requirement traced to a design decision, and every decision traced to a test that demonstrates it. Retrofitting this after the fact is close to impossible, which is why it has to shape the architecture from the start.
Software of unknown provenance
Third-party libraries and vendor stacks need justifying, not just importing. That constrains platform choices in ways that surprise teams arriving from consumer product work.
Change is expensive
A one-line fix carries a documentation and re-verification cost. Designing so that likely changes stay inside a bounded area is worth real effort up front.
Long service life
Devices outlive their component supply chains and their operating systems. The update and patching path is part of the safety case, not a feature.
Where our scope ends
We are engineers, not a regulatory consultancy. We build to the standard your quality system requires and produce the evidence it needs, but we do not write your QMS or act as your notified body interface.
Practices this draws on
How the work is usually staffed
01
Embedded Systems Engineering
Firmware, drivers and board bring-up for products that have to work for a decade in the field.
04
Embedded Linux & Edge Platforms
BSPs, Yocto builds, RTOS decisions and the platform work everything above it depends on.
02
Photonics & Industrial Vision
Optics, illumination and imaging chains, from sensor selection through to a working inspection result.
Bring us the challenge
The one that has been handed back, sits between two suppliers, or nobody can say is possible yet. A short call costs you nothing and you will speak to one of our consultants.
Engineer to engineer. No handoffs.