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, across ALM systems, external sources, and files. Traceability is not just a compliance artifact: it drives development forward, surfaces gaps before they become findings, and continuously assembles a complete Technical File.
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 By the time the project is ready for review, the matrix is out of date and the reconciliation effort delays release.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. The traceability graph detects gaps as they open, keeping teams focused on design and delivery rather than documentation maintenance.
Traceability matrices are continuously aligned to IEC 62304, ISO 14971, and your own quality SOPs, providing a complete Technical File at every point in the lifecycle.
Traceability matrix: live coverage across requirements, changes, and risks mitigated. Every link is maintained automatically as the project evolves.
Standards Addressed
Built to satisfy the standards that matter most to your auditors.
See it in action.
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 EnterpriseBuilding 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 EnterprisesLegacy Regulated Software Remediation
Regulatory debt is locking your legacy software. P4SaMD clears the path to certification, without rebuilding from scratch.
Read Use CaseFind the right plan for your team.
From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.
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compliant software faster?
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