From 2026 every Class IIb/III device must collect continuous, structured real-world evidence. Most manufacturers still rely on paper forms that disappear in 40–60 % of cases and cost £25k–£80k per 1,000 evaluations to chase.

Medisphere AX gives you three things no other platform can:

• 100 % of your existing form digitised – surgeons keep the exact layout they already know.

• >98 % same-day capture – magic-link, no login, no app, instant e-signature and lot scanning.

• The only blinded benchmark pool – see exactly how your product performs against every competitor in real theatres, without ever revealing identities.

Result: instant PSUR/PMCF reports, perfect audit trail, faster Notified Body sign-off, and the strongest clinical evidence you’ve ever shown to procurement or payers.

Founding Manufacturer Programme – limited to the first 20 partners

• Locked-in grandfather pricing (£80k/yr forever)

• Co-branded case studies with NHS reference sites

• Priority access to the blinded pool from day one

• Input into roadmap (multi-centre trials, implants module, US expansion)