06 — BROWNFIELD

Brownfield Remediator

Certify what you already built, without rebuilding it.

Provides dedicated capabilities to ingest existing applications of any codebase, run automated gap analysis against reference standards, and generate custom remediation plans that move legacy software toward certification without a full redevelopment.

What It Does

From legacy software to audit-ready evidence.

Millions of lines of medical device software were written before IEC 62304 was a consideration and before EU MDR came into force. This software still works and creates value, but it cannot be certified, updated, or brought to new markets without satisfying the regulatory frameworks it predates.

The Brownfield Remediator ingests your existing software regardless of programming language or documentation maturity, automates the gap analysis, reconstructs traceability from disconnected artifacts, and generates a structured, sprint-ready remediation backlog.

Key Features

Automated Ingestion

Import any codebase, any format

Imports heterogeneous workitems (requirements from Word, risks from Excel, tests from any test management tool, code from any Git repository) into P4SaMD's unified compliance model without manual migration.

Gap Analysis

Deviations from IEC 62304 and ISO 13485, surfaced automatically

The P4SaMD Compliance Engine maps existing artifacts to reference standards and identifies every gap (what's missing, what's incomplete, what's non-conformant) with prioritized remediation effort estimates.

Traceability Reconstruction

ARTT rebuilds what was never built

Using ARTT, the Brownfield Remediator reconstructs end-to-end traceability from existing artifacts even when no explicit traceability was ever defined.

Remediation Planning

Sprint-ready backlog of prioritized compliance tasks

Generates a structured remediation backlog organized by regulatory priority and effort that engineering teams can import directly into Jira or any ALM tool and begin executing immediately.

Standards Addressed

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

IEC 62304ISO 13485EU MDR 2017/745FDA

Related Use Cases

See it in action.

For Pre-Market Startups & Scaleups

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