Independent assurance, and the evidence to earn it
oDIX8 assesses clinical-AI tools we did not build and do not sell, and helps the teams that build them generate evidence a commissioner, a regulator or a board will actually accept. Every service rests on published method, not a brochure.
Commission Readiness Check
Where your clinical AI stands against the UK National Commission’s 44 recommendations, your exposures ranked, and a concrete remediation route for each. Fixed fee, ten working days, no patient data.
Start the free self-check →Independent AI assurance & audit
We exercise your declared workflow with synthetic probes and grade it with the verdict separated from production, so the result stands up to a second party and a third. You receive a findings register and a framework crosswalk (DCB0129, ISO 14971, EU AI Act).
Clinical studies & habilitated-GP evaluation
We design and run evaluation studies with habilitated general practitioners, through an academic primary-care network, so your tool is tested in the conditions it will actually meet.
Outcome-evidence pipeline
A pipeline that produces outcome evidence mapped to current regulatory expectations and ready to hand over, rather than reconstructed under deadline.
Endpoint engineering & reviewer defense
Pre-registered, regulator-fit endpoints, with BfArM and EU requirements in view, and a reviewer-defense pack that anticipates the objections before they are raised.
Founder-to-clinic translation
We translate a founder’s model into something a clinic can adopt, with the architectural decisions that actually determine adoption made explicitly, not left to chance.
Not sure where you stand?
Take the free 3-minute self-check, or talk to us about any of the above.
Free self-check Talk to usEvery service is grounded in peer-reviewed and open-access work. See the research →