Seven areas where this team already has design depth, across more than forty devices designed and developed. The applicable standards, the failure modes and the test laboratories differ by domain.
Seven device types
Find your device type: what makes it hard, what we ask first, and the standards to plan for from the start.
Tests whose result matches the patient's condition.
What makes it hard
Sample handling. Small volumes, clotting, haemolysis and carry-over all move the result.
Tell us first
The analyte, the sample type and the sample volume.
Standards that often apply
ISO 18113, ISO 20916, IEC 61010-2-101.
Instruments that survive reprocessing and feel right in a surgeon's hand.
What makes it hard
Reprocessing. A reusable instrument must survive hundreds of cleaning and sterilisation cycles without losing its function.
Tell us first
The procedure, and the step where the instrument is used.
Standards that often apply
ISO 10993-1, ISO 17664, ISO 11607.
Devices we have built here
7, including a pulsed lavage irrigation system for orthopaedic surgery.
Equipment that runs for days on end and never fails quietly.
What makes it hard
Continuous duty. Equipment runs for hours or days and must not fail quietly.
Tell us first
The setting: ward, ICU, operating theatre or transport.
Standards that often apply
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8.
Devices we have built here
4, including a blood and fluid warmer, in two flow ranges.
Devices that deliver the right dose, even in untrained hands.
What makes it hard
Dose accuracy. The delivered dose, not the set dose, is what has to be proven.
Tell us first
The drug, its form and the dose range.
Standards that often apply
ISO 11608, ISO 20072, ISO 80369.
Monitors and wearables whose readings a clinician can trust.
What makes it hard
Accuracy against a reference. The number has to agree with a clinical reference, across the population that will use it.
Tell us first
The parameter you measure, and the accuracy you claim.
Standards that often apply
IEC 60601-1-11, IEC 80601-2-30 / ISO 81060-2, IEC 60601-2-47.
Devices we have built here
5, including a continuous glucose monitoring sensor.
Devices a patient lives with, from limb prostheses to infant care.
What makes it hard
Loads over years. Prostheses and orthoses carry the body's weight every step, for years.
Tell us first
The users: age, weight and activity, or the neonatal care setting.
Standards that often apply
ISO 10328, ISO 22523, IEC 60601-2-50.
Clinical software whose output a regulator will accept.
What makes it hard
The dataset. Labelled by clinicians, representative of the people it will be used on.
Tell us first
The clinical question, and who acts on the output.
Standards that often apply
IEC 62304, IEC 82304-1, ISO 14971.
Devices we have built here
One: diagnostic-support software built on a clinical data platform.
Three free tools that run in your browser and send us nothing: a readiness check, an intended use builder and your likely class and licence.
