Medical Devices

SaMD lifecycle governance under FDA and IEC.

Software-as-Medical-Device (SaMD) classification, predetermined change control plans, IEC 62304 lifecycle alignment, and post-market surveillance for AI/ML enabled devices.

FDA SaMD Guidance

IEC 62304

ISO 14971

21 CFR 820 QSR

EU MDR

Vertical-specific sub-modules

2 modules purpose-built for MedDevice

Each sub-module addresses a specific obligation in this vertical that the platform's 12 core modules combine with to give you full coverage.

FDA Device Classification

510(k) vs. PMA pathway selection and submission support.

Device Safety

Adverse-event correlation and post-market surveillance.

Plus the platform foundation

Every vertical inherits all 12 core platform modules

Vertical-specific sub-modules sit on top of Pratvi AI's full platform — model inventory, audit trail, bias monitor, drift, security posture, explainability, and more all apply uniformly across every vertical.

AI Model Inventory→Compliance Engine→Immutable Audit Trail→Bias & Fairness Monitor→Drift & Performance Monitor→Security Posture (MITRE ATLAS)→Explainability Engine→Confidence & Verification→Adverse Action Notice Engine→Evidence & Incident Workbench→Executive Dashboard→Agentic Governance Layer→

See how Pratvi handles MedDevice specifically

30-minute walkthrough. No commitment. Bring your specific regulatory exposure and we'll map it to platform capabilities live.

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