DDF Flow
FDA Regulatory Intelligence
Your automated
DDF documentation builder
Now with free FDA submission classifier & 510(k) predicate finder. Try it today.
Describe your device once. DDF Flow classifies the FDA pathway, assembles the complete 90+ document tree, drafts every section, and wires it into a live, traceable, audit-ready file — in minutes, not months. Auto-traces requirements from User Needs to Test Cases. DDF (Design & Development Files), formerly known as the DHF (Design History File), is the intelligent design-control record behind every FDA submission.
Free to start · Classify your first device and explore the full document tree
Design & Development Plan
Master plan defining the design & development process, phases, team responsibilities, milestones & deliverables per 21 CFR 820.30(b) and ISO 13485 §7.3.
3.1 Technical & Operational Assumptions
The CLOBA-1000 uses a 650nm Class 1 laser with ≤50ms capture latency and hardware-coupled torque limits of 0.3 N·m…
3.2 Critical Technical Risks
SoC failure could freeze the HMI; mitigated via dual-processor architecture. Refractive noise and 316L blade mechanical fatigue tracked…
Full traceability from user needs through design inputs (DIR) to test cases — per 21 CFR 820.30.
25
User Needs
52
DIR Reqs
48
SRS Reqs
110
Test Cases
10 ways DDF Flow builds your submission
Every manual regulatory task — now automated end to end.
FDA Pathway Classifier
DDF Flow reads your device intake and classifies the FDA pathway — 510(k), De Novo, PMA, or Exempt — with applicable regulations and standards.
Device Profile Setup
Describe your device once; the Auto-Draft system builds the full profile narrative every downstream document is built from.
510(k) Predicate Finder
DDF Flow searches the FDA database and scores predicate devices for substantial equivalence, with a strategic rationale.
90+ Document Generation
DDF Flow assembles the complete DDF/DHF document tree — 90+ templates — with the right documents added automatically based on your classification and regulatory pathway.
Full Document Drafting
The Auto-Draft system drafts every section tuned for FDA design controls — regenerate, refine, or write and let it expand your content.
Document Export
Export clean, audit-ready DOCX with tables, images, and requirements intact — one click.
Traceability Matrix & Auto-Tracing
DDF Flow extracts requirements and builds a live trace matrix across needs → inputs → outputs → V&V.
Document Insights
Per-document interview questions shape each document to your specific device and use case.
Facts Registry
DDF Flow auto-extracts technical facts and flags cross-document changes before they become conflicts.
Regulatory Auditor
The Auditor reviews your submission narrative across the whole file — conflict-free, consistent, submission-ready.
How it works
Build your DDF in 4 steps
Work top-down: facts → strategy → documents. Everything downstream inherits what you set upstream.
Build your Device Profile
The facts every document is built from. Describe your device once and let the Auto-Draft system build the whole profile, then refine.
Set strategy in your Plans
Open each Plan and answer its interview. These strategic decisions cascade automatically into every document they govern.
Generate the documents
Open any document and draft section by section. Downstream documents auto-pull from your facts and plans.
Check consistency and export
Run the Auditor to catch contradictions across the file, then export your DHF/DDF as a consistent story.
Pricing
Simple, credit-based plans
Pick a monthly credit allowance. Top up anytime. Cancel anytime.
Starter
For a solo regulatory lead building their first submission.
- Full FDA classification engine
- 90+ document tree & auto-drafting
- Predicate finder, FMEA & risk tools
- Traceability matrix & facts registry
- DOCX export
Pro
For teams running multiple submissions in parallel.
- Everything in Starter
- 2.25× more monthly credits
- Priority generation
- Team seats at $49/mo (shared credits)
- Auto-recharge & one-time top-ups
Add team seats — $49 / month each
Every additional user shares your main account's credit pool — no separate billing. Seats draw from your monthly credits.
Need more credits? Top up anytime
1,000 credits
One-time purchase
2,500 credits
One-time purchase
Auto-recharge
Turn on auto-recharge in Settings → Billing. When your balance drops below 500 credits, we automatically add 1,000 credits so your work never stops.
Ship your FDA submission,
not your evenings.
Classify your first device free — no credit card required. Have a full, traceable DDF in minutes.