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The Regulatory Guardrail Build

A fixed-scope, 14-day architectural build to eliminate dangerous regulatory drift by anchoring your AI coding agents in a deterministic understanding of your SaMD and clinical regulatory domain.

The Regulatory Guardrail Build

14-Day Architectural Build
€19,500 (Excl. VAT)
All prices exclusive of VAT
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The Problem

Large Language Models excel at generating code quickly, but they operate entirely on statistical probabilities. They do not know your unwritten clinical invariants, ePHI isolation boundaries, or strict regulatory constraints. When unleashed on a mission-critical healthtech codebase, development agents confidently guess. They invent parallel clinical workflows and unauthorized data paths, creating rogue compliance logic. This pushes a massive cognitive load downstream, taxing your most senior engineers with untangling hallucinated clinical logic and ePHI boundaries during code review.

The Solution

I extract the compliance logic currently relying on manual code reviews or probabilistic 'LLM-as-a-judge' validation and codify it into a formal regulatory domain model using localized Domain-Specific Languages (DSLs) and the Z3 Theorem Prover. Plugged into your agentic development workflow, it instantly triggers verification checks with mathematical determinism, forcing development agents to self-correct against FDA, MDR, and HIPAA reality before a single line of code is written.

Why This Works

Audit-Ready AI Compliance: By translating clinical invariants and ePHI access states into an executable domain boundary, you generate deterministic proof that your AI cannot violate system safety. You can safely scale agentic coding workflows while automatically generating a formal Compliance Bill of Materials (CBOM) for every agentic execution.
Intercepting Regulatory Tech Debt: By establishing the formal regulation-grounded domain model as your executable single source of truth, conflicting specifications or hallucinated state transitions trigger immediate mathematical failures via formal verification. This blocks the agent from drafting a non-compliant pull request.
Protected Engineering Bandwidth: Instead of senior engineers burning hours acting as manual AI compliance-checkers, the drop-in agentic hooks enforce your MDR/HIPAA boundaries upfront, protecting your team's cognitive load.
Immediate Talent ROI: If a €150k+/year senior engineer spends just 5 hours a week untangling hallucinated compliance logic, they are wasting over €18,750 of capacity annually. By intercepting these errors deterministically upstream, this fixed-scope build eliminates the PR bottleneck, paying for itself entirely within weeks.

Methodology & Timeline

Delivery Mechanics for the 14-day build:

1

Targeted Domain Extraction (90-Minute Session)

A single, high-efficiency working session with your leads to pinpoint high-leverage targets and existing ground-truth rules (e.g., FHIR contracts, clinical data schemas, ePHI boundaries).
2

Guardrail Engineering

I independently extract and formalize your clinical rules into a formal domain model and executable verification gates to act as the regulatory guardrail for your agentic development workflow. I tailor the automated verification hooks to your existing agentic development environment.
3

Air-Gapped Delivery & Zero-Access Integration

I do not require access to your live CI/CD pipelines, internal networks, or sensitive source code. The compiled domain model, invariant baseline and agentic plugins are delivered as self-contained artifacts, bypassing InfoSec bottlenecks.
4

Interactive Handover & Automated Verification

During the Day 14 live handover, we run self-contained validation test fixtures inside your local environment, demonstrating the guardrail actively intercepting hallucinated regulatory logic and proving determinism across real agent workflows.

What You Walk Away With

Core Deliverables owned by your engineering team at the end of the 14-day build:

The Formal Domain Model & Invariant Baseline: A formal, machine-readable DSL defining a single, high-value regulatory slice (a bounded context). It strictly maps the exact clinical rules, ePHI state transitions, and regulatory constraints your agents must respect.
The Drop-In Agentic Guardrail: I deliver the exact plugin components (agentic skills, hooks, and tools) that force your existing agentic setup to comply with the domain model. Crucially, this guardrail automatically produces a formal Compliance Bill of Materials (CBOM) for every approved execution.
IEC 62304 / CSA Validation Fixtures: I provide self-contained deterministic test scripts (Agentic Red Teaming) that prove the guardrail intercepts invariant breaches 100% of the time, drastically accelerating your internal QA/RA tool-validation paperwork.
The Architectural Evolution Runbook: To ensure your team retains 100% independent authority, I deliver a definitive maintenance runbook for your senior engineers. It provides the step-by-step workflow for your team to easily update and extend the DSL boundaries as your clinical business rules evolve.

Financial Structure & Authorization

Structured as an Operational Velocity Investment of €19,500 (Excl. VAT), sized specifically to fall within standard VP of Engineering / CTO discretionary spending limits. The build commences upon mutual execution of the Statement of Work (SOW).

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Satisfaction Guaranteed

Outputs vs. Engine IP Model: The client retains 100% ownership of all customized deliverables (the compiled domain model, the DSL schemas, Z3 verification rules, AI skills, and hooks). Arvoan retains exclusive ownership of its Background IP, granting the client a perpetual license to utilize these embedded tools for internal operations.

Operational Assumptions: Maintaining the fixed-scope 14-day delivery timeline depends on timely feedback from designated technical stakeholders and a standard 48-hour SLA on intermediate schema reviews. In the event that internal operational priorities require a review pause, the 14-day delivery clock halts day-for-day, safeguarding architectural thoroughness without cutting corners.