05 — AI

Master AI for Compliance

Ship AI-enabled medical software with full regulatory clarity.

A dedicated feature set that enforces the specific regulatory requirements of AI-enabled medical software: transparency, explainability, audit logbooks, and data quality. Supports EU AI Act, GMLP, and FDA PCCP frameworks.

What It Does

The compliance infrastructure for AI-enabled SaMD.

AI components enable smarter diagnostics and adaptive workflows, but they also introduce a new layer of regulatory complexity. The EU AI Act, FDA GMLP, and PCCP frameworks demand documentation and control practices that standard QMS systems were never designed to support.

Master AI for Compliance adds a dedicated layer within P4SaMD that enforces transparency, explainability, and logbook requirements while supporting structured documentation of AI training data, model versions, performance metrics, and PCCP change control plans.

Key Features

AI Transparency Framework

EU AI Act Annex IV requirements, enforced

Automatically generates and maintains AI system transparency documentation required by EU AI Act Annex IV, including intended purpose, performance metrics, data quality assessments, and human oversight provisions.

PCCP Support

Model updates without full re-submission

Structured support for FDA Predetermined Change Control Plans, enabling teams to plan and execute model updates within pre-approved boundaries, avoiding the cost and delay of a new regulatory submission for every algorithm iteration.

Model Logbooks

Automated tracking of every model state

Automated logbooks track training data characteristics, model versions, performance benchmarks, validation results, and bias assessments, creating the continuous record that regulators require for AI-enabled SaMD.

AI Risk Management

ISO 14971 extended for AI failure modes

Extends the ISO 14971 risk management framework to cover AI-specific failure modes including data drift, distribution shift, algorithmic bias, and performance degradation over time.

Standards Addressed

Built to satisfy the standards that matter most to your auditors.

EU AI ActGMLPPCCPEU MDR 2017/745FDA

Related Use Cases

See it in action.

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