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Mia-Care P4SaMD
06 — BROWNFIELD

Brownfield Remediator

Certify what you already built, without rebuilding it.

Provides dedicated capabilities to ingest the full legacy software estate — documentation (requirement analyses, specs, architecture designs, test plans, test reports, project plans) and technical assets (source code, DB schemas, SBOMs, configuration files) — run automated gap analysis against the applicable regulatory framework, and generate custom remediation plans that bring legacy software to audit readiness without a full redevelopment.

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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 full legacy estate regardless of format, language, or documentation maturity. It automates gap analysis against the regulatory framework of your choice, maps what exists to what is required, and generates a structured, prioritized task list — turning a scattered legacy archive into an audit-ready compliance record.

In Action
Dashboard
Brownfield
Import
Gap Analysis
Remediation Plan
Mia-Care Dev›App Cardio-Monitor›Import
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Overview
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Use case
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Target
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Technical Asset
Import Project
Ready to dive in? Here's how to bring your project to life
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Use case definition
Identifying the problem and selecting classic use cases
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Target Definition and Regulations
Indicate intended use, market region, regulatory frameworks, and classification
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Technical Assets
Upload Database, repository, source code, test results, architecture
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Documentation
Upload PDF, link, wiki, technical and regulatory documentation
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Import wizard — ingest the full legacy estate: documentation (requirement analyses, specs, architecture, test plans, test reports), technical assets (source code, DB schemas, SBOMs), and data from any format. Everything flows into P4SaMD's unified compliance model without manual migration.

Key Features
Automated Ingestion

Import any documentation, any technical asset

Ingests the full legacy estate into P4SaMD's unified compliance model: documentation (requirement analyses, specs, architecture designs, test plans, test reports, project plans) and technical assets (source code, DB schemas, SBOMs, configuration files) — no manual migration required.

Gap Analysis

Gaps against the applicable regulatory framework, surfaced automatically

The P4SaMD Compliance Engine maps existing artifacts to the regulatory framework of your choice — IEC 62304, ISO 13485, EU MDR, FDA, ISO 14971, or any newly applicable regulation — and identifies every gap: what's missing, incomplete, or non-conformant, with prioritized remediation effort estimates.

Legacy Remediation

From compliance gaps to audit-ready evidence

Translates the gap analysis output into a structured remediation path: missing documentation is scaffolded, non-conformant artifacts are flagged with corrective actions, and partial traceability is extended — producing the evidence package that auditors and notified bodies require.

Remediation Planning

Structured, prioritized task list for compliance remediation

Generates a structured, prioritized remediation task list organized by regulatory priority and effort that teams can import into any ALM tool and begin executing immediately.

Standards Addressed

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

IEC 62304ISO 13485ISO 14971EU MDR 2017/745FDACustom Frameworks
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
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