Case studies

Programmes, and what came out of them.

Devices developed, validated, cleared and built.

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Diagnostic

Cleared for market with agreement against the reference standard demonstrated across the full intended population.

Therapeutic

Safety case built alongside the design, with every risk control traced to a verification result.

Drug delivery

Dose accuracy held across the full delivery range through transfer and into sustained production.

Diagnostic

Laboratory-comparable performance evidenced in the ward, the clinic and the home.

Therapeutic

Production established under our own quality system with unit-level traceability from lot to shipped device.

Drug delivery

Injection force specified from measured population hand strength, then validated with real users.

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