The Syntax Method

At Syntax Regulatory, we don't believe in manual bottlenecks. We integrate directly into your development lifecycle to ensure your Design History File (DHF) evolves at the same speed as your code.

1. Seamless Kick-off

We join your team the moment you kick off Design Controls. Whether you are at the "User Needs" stage or already drafting "Design Inputs," we plug into your existing workflow (Jira, GitHub) to start building your regulatory foundation immediately.

2. Radical Flexibility

We scale with your sprint cycles. Unlike traditional firms that demand rigid retainers, we offer a "sliding scale" of support:

Low-Touch Guidance: As little as 8 hours per week for high-level oversight and audit-readiness checks.
Full-Scale Execution: No upper limit. We can act as your dedicated Quality and Regulatory arm during heavy submission pushes.
Flexible & Cheapest Rates: We believe in partnership over transactions. We work with your budget to ensure compliance is accessible, not a barrier.

3. AI-Powered Automation

We use AI Models to customize automation tasks specifically for your program’s needs.

Automated Traceability: We use AI to map requirements to test cases, flagging gaps in real-time.
Smart Documentation: AI Model helps us draft and refine technical descriptions and risk assessments, ensuring they meet FDA/ISO standards while saving you weeks of manual writing.
Custom Tooling: If your program has a unique need, we build a custom AI prompt or script to automate that specific compliance task.

"We automate the bureaucracy so your engineers can focus on the breakthrough."

4. Total DHF Stewardship

Once you are onboarded, the "Regulatory Headache" is ours to manage. We take full ownership of your Software Design History File (DHF), including:

Maintaining the Traceability Matrix.
Managing Software Verification & Validation (V&V) reports.
Ensuring Risk Management files (ISO 14971) stay updated with every code change.
Preparing your documentation for FDA 510(k) or CE Mark submissions.