---
title: "KYE™ Medical Device SaMD Authority Pack™ — Software as a Medical Device · KYE™ Sector Pack Foundry™ · KYE Protocol™"
description: "The Medical Device SaMD Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for Software as a Medical Device. Maps every AI-assisted SaMD decision to a named clinical responsible person, the MHRA SaMD / MHRA MDR / MHRA PMS / EU AI Act / ISO 42001 obligation it discharges, and the signed Evidence Pack™ it emitted."
url: https://kyeprotocol.com/foundry/medical-device-samd-authority-pack/
lang: en
source: "KYE Protocol"
---

> The Medical Device SaMD Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for Software as a Medical Device. Maps every AI-assisted SaMD decision to a named clinical responsible person, the MHRA SaMD / MHRA MDR / MHRA PMS / EU AI Act / ISO 42001 obligation it discharges, and the signed Evidence Pack™ it emitted.

KYE™ Sector Pack Foundry™

# 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.

[Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) See the 8-step pipeline Bound regulatory perimeter

## 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](https://kyeprotocol.com/clinical-ai/) view for the wider AI-assisted clinical decision picture.

## Qualified partners — apply through the Foundry.

[Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) [See the three Foundry tiers](https://kyeprotocol.com/sector-pack-foundry/) [Bound regulatory frameworks](https://kyeprotocol.com/frameworks/)

## Canonical surfaces

This Pack is one projection of the [KYE™ Sector Pack Foundry™](https://kyeprotocol.com/sector-pack-foundry/) — the productisation rail of [KYE Protocol™](https://kyeprotocol.com/). Every in-scope decision emits a signed [Evidence Pack™](https://kyeprotocol.com/evidence-pack/).