Brownfield Import — Overview
The Brownfield Import feature allows you to onboard an existing software project — one already in development or even in production — into P4SaMD. The platform analyzes your current state against the applicable regulatory framework and produces a prioritized compliance gap analysis and a remediation plan you can act on immediately.
Use this feature when your software product already exists but has not been developed under a formal IEC 62304-compliant process, when you need to understand the gap between your current state and EU MDR or FDA certification requirements, when you want to generate a structured roadmap to bring an existing product to audit-ready status, or when you are acquiring or inheriting a system and need to assess its regulatory posture.
How It Works
The process has two phases. First, a guided six-step wizard where you describe the project, upload technical assets, and provide existing documentation — this takes approximately 30–60 minutes depending on the volume of materials. Second, an asynchronous evaluation in which P4SaMD processes your uploaded materials and produces a compliance gap analysis and a prioritized remediation plan. You can track evaluation progress on the Evaluation page and return to it at any time while processing is underway.
The six wizard steps are:
| Step | Name | What you provide |
|---|---|---|
| 1 | Import Project | Review the process and what to prepare |
| 2 | Use Case | Reason for the assessment (e.g., Regulatory Change, Delta Certification, Add Feature, Audit Preparation) |
| 3 | Target Definition | Target regulatory framework, device class, intended use, and target market region |
| 4 | Technical Assets | Source repositories, CI/CD configurations, build artifacts, and development toolchain details |
| 5 | Documentation | Existing design documents, SOPs, test reports, risk analyses, and other compliance evidence |
| 6 | Summary | Review all inputs before submitting for evaluation |
You can pause at any time by clicking Save as Draft in the wizard footer. Your session is saved and listed as a draft in the Brownfield section of the left sidebar. Click Resume on the draft card to pick up exactly where you left off. To exit without saving, click Cancel and choose Exit without saving — if you have never saved the session as a draft, no data is stored.
After Evaluation
When evaluation completes, the Evaluation page shows an overall compliance score (the percentage of the target framework currently satisfied), a gap analysis breakdown categorized by area with a severity rating for each gap, and a remediation plan organized by compliance area (Requirements, Design, Risk Management, Software Implementation, Verification, Configuration). Each task is assigned a priority (Critical, High, or Low) based on its impact on your regulatory target. The plan starts as an editable draft — you can review, reassign, and reorder tasks before confirming it. Once confirmed, you track task completion per area.
Evaluation Progress
While the evaluation is running, the Evaluation page displays real-time progress through four processing phases:
- Document Preparation — uploaded files are normalized and prepared for analysis
- Document Extraction — relevant content is extracted from your technical assets and documentation
- Payload Crafting — extracted data is structured against your target regulatory framework
- Evaluation — the compliance gap analysis is computed and the remediation plan is generated
Progress updates appear in real time — you can leave the page and return at any time without losing your place.
Evaluation Metrics
After evaluation completes, two key metrics are highlighted:
- Compliance Health Score — an overall percentage indicating how much of the target framework is currently satisfied by your existing documentation and processes
- Traceability Coverage — the degree to which your existing artifacts are traceable across lifecycle phases (requirements → design → implementation → verification)
Exporting Results
You can export the evaluation results for use in external reports or regulatory submissions. Available export formats include PDF (for human-readable compliance reports) and CSV (for data import into other tools or spreadsheets). Click Export on the Evaluation page and select your preferred format.
Where to go next