Clinical trust, designed as architecture.
MedETechni does not treat compliance as a document. We implement it directly in code: every AI module has human-in-the-loop, consent binding, ISO 14971 hazard analysis, and tamper-evident auditing — verifiable in 5 seconds.
Reference standards
Aligned with real-world clinical and privacy frameworks
ISO 13485
Medical device quality management
IEC 62304
Medical device software lifecycle
IEC 62366-1
Usability engineering for medical devices
ISO 14971
Risk management for medical devices
GDPR Art. 35
Data Protection Impact Assessment
HIPAA
Administrative · Physical · Technical safeguards
FDA AI/ML SaMD
Software as a Medical Device guidance
Controls implemented in code
6 layers of clinical defense active today
Human-in-the-Loop Enforcement
Mandatory clinician confirmation before any P0/P1 clinical output can be finalized, exported, or linked to another AI module. Override reasons required when the clinician contradicts AI.
Consent Linking (HARD BLOCK)
Active patient consent is required before running clinical AI on high-sensitivity or health data. Consent ID is cryptographically bound to every HITL decision and audit event.
Granular RBAC
12 clinical roles × 28 modules × 11 actions. Every denied action is logged to tamper-evident audit trail.
Tamper-Evident Audit Trail
Every HITL confirmation, override, permission denial, and model version produces a SHA-256 hashed entry in an append-only ledger.
ISO 14971 Hazard Register
Formal hazards documented per module with severity × probability risk matrix and verified mitigations linked back to the UI controls.
DPIA per P0 Module
Full GDPR Article 35 Data Protection Impact Assessment for every high-sensitivity module, including data categories, transfer mechanisms, and residual risk.
28
AI modules with regulatory classification
26
ISO 14971 hazards documented
13
Approved DPIAs (GDPR Art. 35)
109
Intended-use claims registered
Enterprise · Under NDA
Request the Audit Pack
The Audit Pack bundles in a single ZIP: SDP IEC 62304, UEF IEC 62366-1, Vendor BAA Registry, cross-reference traceability matrix, and compliance data snapshots. Available only to auditors, hospitals or partners under NDA.