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Mia-Care P4SaMD
05 — AI

Master AI for Compliance

Ship AI-enabled medical software with full regulatory clarity.

A dedicated feature set for AI-enabled SaMD that enforces transparency, explainability, audit records, and data quality requirements across the full compliance lifecycle of AI components, agents, and models.

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What It Does

The compliance infrastructure for AI-enabled SaMD.

AI components, agents, and models are transforming SaMD products, enabling smarter diagnostics, adaptive workflows, and better patient outcomes. But they introduce a regulatory complexity that standard QMS systems were never designed to handle: the EU AI Act, FDA GMLP, and PCCP frameworks demand transparency, explainability, audit records, and data quality controls that go far beyond traditional software compliance.

Master AI for Compliance adds a dedicated layer within P4SaMD that manages the full compliance lifecycle of AI components, from design inputs and regulatory review through implementation adherence, quality assurance, and documentation. It enforces transparency, explainability, and audit record requirements, and supports structured documentation of AI training data, model versions, performance metrics, and PCCP change control plans.

In Action
Dashboard
SDLC
Workflow Guide
Requirements
Software System
Verification
Risk Analysis
Security
Documentation
Configuration
Product Metadata
Regulatory Framework
AI Agents
Users
Mia-Care Dev›AI Diagnostic Tool›Software System
System Design
Software architecture and component hierarchy
Software Items
System Context
10
Total Components
Software Items (Design)
</>Cardio-Monitor Core
›</>Signal Processing Engine
›</>ML Anomaly DetectionAI Agent
›</>Data Storage Layer
›</>Frontend Application
AI Inventory
Manage AI Models and Datasets
Sub-section

System Design: component hierarchy of the AI Diagnostic Tool, with ML Anomaly Detection auto-identified as an AI Agent requiring a dedicated compliance lifecycle under EU AI Act and IEC 62304.

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. No new regulatory submission for every algorithm iteration.

AI Component Audit Records

Automated tracking of every model state

Automated audit records track the full lifecycle of every AI component, agent, and model: training data characteristics, version history, performance benchmarks, validation results, and bias assessments. The continuous record regulators and notified bodies require.

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.

For Pre-Market Startups & Scaleups

SaMD Greenfield Development

Building a SaMD from scratch means two simultaneous challenges: writing the software and satisfying the regulator. P4SaMD makes them the same phase.

Read Use CaseFor AI-Native SaMD Enterprise

Building High-Risk AI Software (CDSS)

AI-based clinical software evolves dynamically, but traditional compliance models assume requirements are static. P4SaMD decouples your engineering velocity from regulatory rigidity.

Read Use CaseFor MedTech Giants & Life Sciences Enterprises

Legacy Regulated Software Remediation

Regulatory debt is locking your legacy software. P4SaMD clears the path to certification, without rebuilding from scratch.

Read Use Case
Pricing

Find the right plan for your team.

From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.

StandardSmall teams
ProfessionalGrowing teams
UnlimitedEnterprise
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