Skip to content

Regulatory and Product Controls

Claim boundary

Architecture, profiles, and these synthesis documents are not FDA clearance or a filed SaMD submission. Live study/model claims belong in the validation evidence index after pivotal runs.

This folder is the regulatory-facing synthesis layer for MethylPipeline. It does not replace the theory, usage, implementation, architecture, deployment, or reference documentation. Instead, it explains how those materials combine into a controlled software product with traceable configuration, deployment, execution, validation evidence, and change management.

Audience

Use these documents for product review, quality-system planning, FDA-style submission preparation, internal design control, and release readiness discussions.

Document Purpose
Regulatory-Ready Platform for Multiomics Diagnostics Product positioning, open-core packaging, GTM, and analyte/process roadmap (strategy). Standalone HTML (offline Mermaid; repo-only, not in the MkDocs site): docs/regulatory/Regulatory-Ready Platform for Multiomics Diagnostics.html — regenerate with scripts/render_regulatory_standalone.sh. Sales pitch deck (Marp; repo-only): docs/presentations/regulatory-ready-platform-multiomics.md (HTML/PDF via scripts/render_presentations.sh).
Product and operational controls Product scope, feature inventory, configuration-as-workflow model, and control summary
Deployment and supervision Production topology, worker supervision, portal monitoring, release bundles, rollback, and security controls
Validation evidence index Template and registry structure for real study/model results tied to exact software and configuration versions
SaMD submission scaffold 510(k)/De Novo-style content map → existing controls (not a filed submission)
Change management plan Proposed change classification, impact assessment, CI gates, release controls, and model revalidation triggers
Continuous integration and regression testing Regression gate, test taxonomy, coverage measurement, per-package test expectation, and CI evidence
Traceability matrix Mapping from product claims and controls to source docs, schemas, tests, and runtime evidence

Operational study path (SaMD ladder)

For creating new healthy-vs-disease studies with real holdouts and a small profile progression (samd_research → samd_holdout_enrichment → samd_pivotal), use the operator SOP:

Relationship to Canonical Docs

Pillar Canonical Location Regulatory Use
Theory ../theory/ Statistical method, assumptions, validation limitations
Usage ../usage/ Operator run paths, artifact gates, troubleshooting
Architecture ../architecture/ System topology and configuration layers
Implementation ../implementation/ Engine, compiler, workers, package boundaries
Deployment ../deployment/ Production release and runtime operations
Reference ../reference/ JSON Schemas, action contracts, DomainProgram language

Maintenance Rule

These documents should cite canonical sources for detailed behavior and should be updated when any change affects intended use, workflow topology, schema contracts, production deployment, worker traceability, release controls, regression testing, or validation evidence.