The Compiler for
Regulatory Arguments.
Compliance Forge is a Compliance Evidence Automation Toolkit that generates audit-ready Technical Files, DHFs, SOPs, Traceability Matrices, and SBOMs from structured data — so you stop spending 60% of your week in Word and start shipping compliant products.
Phase 1 MVP: EU MDR & FDA 21 CFR Part 820 → H2 2026
device: Class II, Flow Valve
standard: EU MDR 2017/745
risk_class: IIa
# Run the forge
$ compliance-forge build
✓ Technical File generated
✓ Traceability Matrix mapped (280 reqs)
✓ SBOM created (42 components)
✓ SOPs drafted (Sterilization + QC)
✓ Audit evidence package ready
# Done in 4 minutes.
The Pain Is Real.
You know the technology. You don't know the regulatory argumentation structure. And the market is flooded with expensive, rigid QMS platforms that don't write content for you.
The Documentation Trap
Engineers spend 60% of their week in Word and Excel, not building products. Every audit brings a mountain of rewritten narratives.
Legacy QMS Shells
Greenlight Guru, MasterControl, Veeva — rigid, expensive ($15k–$100k/yr), and they never actually write the content for you.
Consulting Bottleneck
Notified Bodies and legacy consultancies charge $5k–$50k per project and still deliver generic templates that need heavy customization.
Product Blueprint: Compliance Forge
A local-first CLI / VS Code Extension + headless CI/CD engine. Think of it as the compiler that turns your engineering data into bulletproof regulatory arguments.
Rust / TypeScript Engine
Blazing-fast, zero-cloud-dependency core logic. Deterministic builds of PDF, HTML, Word, and SBOM from YAML/JSON/ReqIF inputs.
CLI Interface
Terminal-native workflow. Log ingestion, control mapping, and artifact generation via a single binary. Fits your existing shell scripts and CI pipelines.
VS Code Extension
Structured editing, live traceability matrices, and one-click preview inside your editor. No context switching to Word.
Headless CI/CD
GitHub Action / GitLab CI templates that auto-generate compliance packages on every tag. Continuous verification, not just annual audits.
Artifacts Generated, Not Promised.
From structured input to audit-ready output. These are the deliverables that usually take weeks of copy-paste.
Built for the People Who Actually Build
Solopreneurs, regulatory consultants, embedded engineers, and CISOs who are tired of paying enterprise prices for empty QMS shells.
🛡️ Compliance Engineers
You know what a compliant system looks like. You just need the engine to stamp out the boilerplate.
👨💻 Solopreneur MedTech Founders
You need the paperwork to get 510(k) or CE mark, not a $50k/year QMS subscription.
🏛️ Regulatory Consultants
Scale your practice by automating the 80% of identical artifacts across clients.
Execution Roadmap
Phased niche focus to stay lean and avoid the enterprise bloat that kills solopreneurs.
Medical Devices (MVP)
Regulations: EU MDR 2017/745, FDA 21 CFR Part 820, ISO 13485.
Artifacts: Technical Files, DHFs, SOPs, Traceability Matrices, SBOMs.
Software & Quality Standards
Regulations: IEC 62304, ISO 14971, ISO 9001.
Artifacts: Software Development Plans, Risk Management Files, Audit Reports.
AI & Cyber-Resilience
Regulations: EU AI Act Annex IV, Cyber-resilience Act.
Artifacts: CERs, TRFs, Security Architecture Docs, Supply Chain Audits.
Stop Writing. Start Building.
ReguPipe is building the tooling that the compliance world didn't know it needed. Solopreneur-viable. Local-first. Zero lock-in.
Early access closes before H2 2026 launch. No spam — only build logs and release notes.