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Mia-Care P4SaMD
02 — ARTT

Automated Real-time Traceability

Every requirement. Every risk. Every line of code. Connected.

Guarantees end-to-end traceability from requirements and risks to design, implementation, and verification by integrating directly with ALM systems and SDLC toolchains in real time. No manual updates. No reconciliation sprints before audits.

What It Does

Traceability that builds itself, continuously.

Manual traceability is the silent killer of regulated software projects. It starts as a spreadsheet and ends as an audit risk. By the time the project is ready for review, the traceability matrix is already out of date.

ARTT integrates directly with your ALM, Git repositories, and risk management toolchain to map every requirement to its design output, every design output to its implementation, and every implementation to its verification evidence, in real time, automatically, every time something changes.

Key Features
Real-time Mapping

Automatic linking as work happens

Requirements are linked to code commits, test cases, and risk controls the moment they're created or modified. The traceability graph is always one step ahead.

Living Traceability Matrix

Always current, always audit-ready

The Design History File traceability matrix is automatically maintained at all times. There is no reconciliation sprint before an audit because the matrix is never out of date.

Risk Integration

ISO 14971 risk items linked to mitigations

Each risk item is automatically linked to its mitigating software items and the corresponding verification evidence, creating the closed-loop risk chain auditors require.

Gap Detection

Missing links surfaced before audits find them

ARTT continuously monitors the traceability graph and alerts when a requirement has no linked test, a risk has no linked control, or a change has no impact assessment.

Standards Addressed

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

IEC 62304ISO 14971EU MDR 2017/745FDAISO 13485

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