Skip to main content
Mia-Care P4SaMD
02 — ARTT

Automated Real-time Traceability

Every requirement. Every risk. Every artifact. Connected.

ARTT guarantees end-to-end traceability from requirements and risks to design, implementation, and verification in real time; even from different sources by integrating ALM systems, external sources and files. Traceability isn't just a compliance artifact — it drives your development forward, surfaces gaps before they become findings, and continuously assembles a complete, consistent Technical File.

Request a Demo →Watch Demo
What It Does

Traceability that builds itself, continuously.

Manual, segmented 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 By the time the project is ready for review, the matrix is out of date and the reconciliation effort delays release.

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, every time something changes. The traceability graph doesn't just record what happened: it drives development forward, detecting gaps as they open so teams stay focused on design and delivery rather than documentation maintenance.

Traceability matrices are continuously tailored to IEC 62304, ISO 14971, and your own plans and quality SOPs — providing a complete, consistent, and correct Technical File at every point in the lifecycle.

In Action
Dashboard
SDLC
Workflow Guide
Requirements
Software System
Verification
Risk Analysis
Traceability Matrix
Configuration
Product Metadata
Regulatory Framework
AI Agents
Users
Settings
Mia-Care Dev›AI Diagnostic Tool›Traceability Matrix
IEC 62304 §5.7 · Requirements ↔ SW Items ↔ Risks ↔ Tests ↔ Changes
Traceability Matrix
0/6
Req. Coverage
0/6
Req. Verified
0/13
Tests Passed
ChangeChange Request
RiskRisk
Passed
In Progress
RequirementChangesRisks Mitigated
SR-R01Critical
User Authentication
Verified
CR-001
RISK-012RISK-015
SR-R02Critical
Real-time Data Acquisition
Verified
CR-002
RISK-003
SR-R03Critical
Alarm Notification
Verified
CR-003
RISK-001RISK-002
SR-R04High
Data Encryption at Rest
Verified
CR-004
RISK-018
SR-R05High
Audit Trail
Verified
—
RISK-022
SR-R06Medium
System Performance Monitoring
In Progress
CR-005
RISK-025

Traceability matrix — live coverage across requirements, changes, and risks mitigated. Every link is maintained automatically as the project evolves.

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 during development, not just before audits

ARTT continuously monitors the traceability graph and surfaces gaps as they open — a requirement without verification, an uncontrolled risk, a change with no impact assessment — keeping development on track rather than catching problems at audit time.

Standards Addressed

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

IEC 62304ISO 14971EU MDR 2017/745FDAISO 13485
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

Many organizations hold valuable legacy software trapped by regulatory debt. P4SaMD provides a structured 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
View all plans →

Ready to ship
compliant software faster?

See how P4SaMD fits into your development workflow.

Request a Demo →