Agentic Governance™ with Authority Finality™ for Software as a Medical Device.
Every AI-assisted SaMD decision — a clinical output, a model-version change, a post-market surveillance signal — mapped to a named clinical responsible person, bound to the obligation it discharges, and signed into an Evidence Pack™ at the moment it happens. The Medical Device SaMD Authority Pack™ is the KYE Sector Pack Foundry™ productisation that lands Agentic Governance™ — every act has authority, every authority has finality — inside MHRA SaMD, MHRA Medical Devices Regulations, MHRA post-market surveillance, EU AI Act, and ISO/IEC 42001-regulated device makers.
MHRA SaMD, MHRA Medical Devices Regulations, MHRA post-market surveillance, EU AI Act, ISO/IEC 42001 — the SaMD perimeter.
Medical-device manufacturers, SaMD developers, and digital-health vendors shipping AI that functions as, or inside, a medical device are inside a named-accountability perimeter — clinical oversight of device outputs, predetermined change control over model versions, and post-market surveillance of signals and incidents. AI-assisted SaMD operations need named-owner accountability and signed, replay-derivable evidence per decision.
Better evidence than reconstructed logs — signed at the moment, derivable from public keys alone.
The dominant evidence today is after-the-fact reconstruction. A KYE Protocol™ Evidence Pack™ plus Authority Finality™ outcome bound to the named clinical responsible person, the obligation discharged, and the delegation chain is materially better evidence: signed at the moment of the decision and Replay-Proof™ against the published JWKS a regulator or notified body can verify offline. KYE™ governs the authority around the model — not the diagnosis itself.
An 8-step pipeline — from AI SaMD decision to clinical record.
The Pack rides the canonical productisation shape: rule pack, dictionary, sector pack, obligation manifest, expert-pack envelope, coverage attestation, SKU row, and this marketing surface. No Foundry-specific framework shape; the protocol evidence layer underneath is identical to every other Pack.
Bound to the canonical SaMD perimeter.
- MHRA Software as a Medical Device supervision & AI change programme (Predetermined Change Control Plan)
- MHRA Medical Devices Regulations (clinical responsibility)
- MHRA post-market surveillance (signal, complaint and incident management)
- EU AI Act (high-risk AI record-keeping, Article 12)
- ISO/IEC 42001 (AI management system)
Regulators of record: MHRA / EU AI Office. See the clinical-AI authority view for the wider AI-assisted clinical decision picture.