Medical / Electronic Devices
Devices that have to work, and have to prove it.
Diagnostic and electronic medical devices, built for reliability, real-world use, and the paperwork regulators expect.
Medical and electronic devices are held to a higher standard. They have to perform, they have to be safe, and you have to be able to show your working. We design with that in mind from the first concept.
Reliability you can show
In practice that means reliability built in rather than tested in later, and controls people can use when they are stressed or untrained. We think through failure modes early, while a fix is still a change in CAD rather than a recall.
A design history that holds up
We keep the documentation moving alongside the design, so the reasoning behind a device is written down while it is still fresh. When a submission or an audit comes, the trail is already there instead of something you reconstruct from memory.
The constraints we design around
Regulation and paperwork
Designing in a way that produces the traceability a submission needs.
Reliability and safety
Thinking through failure modes early, because a field failure is expensive.
Use under pressure
Controls and ergonomics that work for real people in real conditions.
