Implementation readiness checklist

Supplement S1

Verify that all AEGIS components are configured before first deployment. Covers DARM, MMM, CDM, regulatory documentation, and CAPA integration.

Device information

Common header

Device name *

Include version number

Intended use *

Reference IEC 62304 or IFU documentation

Author name *

Author role *

Date *

Organisation *

Regulatory context

Supplementary S1.1

Risk classification *

Regulatory pathway *

PCCP planned *

DARM configuration

Supplementary S1.2

Three dataset splits defined (Training D_T,k, Golden D_G, Drifting D_D,k)

Golden dataset locked, hashed, and documented before first deployment

Patient/sample deduplication across splits confirmed

Label governance process documented (adjudication criteria, reviewer IDs)

Dataset versioning and provenance metadata system in place

Data accumulation rule documented: D_T,k+1 = D_T,k ∪ D_D,k (unconditional)

MMM configuration

Supplementary S1.3

Primary metrics selected and clinically justified

MLcps weights defined and traced to risk assessment

Drift detection method selected with feature set specified

Fairness metrics defined across relevant subgroups

KPI historical database structure defined

CDM configuration

Supplementary S1.4

Active decision categories defined and clinically justified

All thresholds derived from ISO 14971:2019 hazard analysis with hazard IDs

CDM condition polarity convention documented

CDM pseudo-code reviewed and implementation verified (Suppl. S3.3)

Logging requirements confirmed (all fields listed in guide/07-audit-trail.html)

Gold standard baseline locked at first APPROVE with version tag

Regulatory documentation

Supplementary S1.5

S2 configuration template completed

PCCP / technical documentation sections drafted

Gold standard baseline documented with metric values and dataset ID

CAPA / vigilance escalation pathway defined

CAPA and PMS integration

Supplementary S1.6

CAPA triggers defined for each decision category

Regulatory escalation contacts identified

MDR Art. 83 / FDA PMS reporting thresholds documented

PSUR schedule established

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