Case studies
From first concept to Article 117: a rugged autoinjector
A rugged autoinjector taken from initial concept through to EU MDR Article 117, with the technical documentation built as the design developed.
August 4, 2026
A rugged autoinjector taken from initial concept through to EU MDR Article 117, with the technical documentation built as the design developed.
Proving a scan-to-device workflow for a custom-fit wearable support device, from proof of concept through initial prototypes to a defined regulatory route.
Concept development, several rounds of silicone prototypes, technical drawings and a mapped regulatory route for an early stage bladder care venture.
“Can you build us a prototype?” is probably the most common opening question we get, and about half the time a prototype isn’t actually what
Every medical device on the UK or EU market has a technical file behind it. It’s the evidence pack that shows your device does what