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.
Valuable software, trapped by regulatory debt.
Many organizations hold valuable legacy software not designed under ISO 13485 QMS or in alignment with IEC 62304. Often, these systems also face technical obsolescence. Manual remediation attempts are expensive, slow, and frequently fail audit review because they lack systematic traceability reconstruction.
The instinct to rebuild from scratch is costly and time-consuming. But without a structured remediation path, the legacy software remains locked, unable to be updated, re-certified, or legally distributed as a medical device in new markets.
A path to certification that doesn't start from zero.
A solution designed to ingest and evaluate legacy systems, establishing a clear pathway for regulatory certification that bypasses full-scale redevelopment and that accelerates re-platforming initiatives with a structured, evidence-based remediation plan that maps gaps to specific standards.
From legacy to audit-ready. Without rebuilding.
Mia-Care P4SaMD ingests existing codebases in any language, along with existing documentation, and leverages agentic AI to automate legacy assessments and identify gaps against IEC 62304, ISO 13485, and EU MDR / FDA.
The platform generates custom remediation plans, automates traceability reconstruction using ARTT, and produces audit-ready documentation in your own templates. What typically takes years of manual effort is compressed into a structured, actionable remediation backlog your engineering team can execute immediately.
Case Study // Consumer Health Enterprise
"A global leader in the consumer health and lifestyle sector, with annual revenues exceeding several billion euros, operating across numerous countries through several globally recognized consumer brands."
Scope
- ✓Automated ingestion of heterogeneous workitems: requirements, risks, tests, and existing code
- ✓Traceability reconstruction via ARTT: generating the complete end-to-end traceability matrix
- ✓Gap analysis against MDR and IEC 62304, with prioritized remediation tasks
- ✓Dynamic generation of audit-ready MDR Technical Files using client templates
Measured outcomes from the field.
The P4SaMD capabilities that power this use case.
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