Accelerate 510(k) preparation
with auditable evidence
and credible predicates.
Identify product codes, credible predicates, and required standards—with citations and review‑ready evidence your RA/QA team can trust.
Supported through these programs
Your end-to-end 510(k) workspace
From initial scoping to submission-ready documentation—everything you need in one intelligent platform.
Project Dashboard
Manage multiple projects, visualize milestones, and track progress through your 510(k) preparation journey. Stay organized with a centralized view of all your regulatory activities.
How Veridocx Works
A structured workflow to accelerate 510(k) preparation.
Each phase expands into ten discrete validation and documentation steps within the workspace.
Device overview
Generate structured device description and intended use.
Product code search
Retrieve candidate FDA product codes with source-linked evidence.
Predicate comparison
Analyze similarity to predicate devices across key equivalence dimensions.
Standards and test mapping
Map FDA-recognized consensus standards and required test methods.
Documentation export
Export submission-ready evidence with audit trail.
Security & Data
Security: TLS 1.2+ encryption, AES-256 at rest, role-based access control, no model training on private data.
All projects are encrypted in transit and at rest. Role-based workspaces maintain audit trails for key actions. Your data remains private and under your control.
Important: Veridocx is an AI software tool for document preparation and research support. It does not provide legal or regulatory advice.
Evidence & Sources
Veridocx synthesizes data from FDA 510(k) and Product Classification databases, Recognized Consensus Standards, and related public sources. Datasets sync nightly.
~7k
Product codes (Nov 2025)
~200k
510(k) records
~2k
Recognized standards
Our Story
We're builders from Computer Science, Computer Engineering, and Biotechnology across the University of Toronto, University of Waterloo, and Arizona State University. After hands‑on work in ML research, data engineering, and med‑device projects, we saw a consistent pattern: regulatory work is mission‑critical, but fragmented and slow.
We're applying frontier AI—responsibly—to make 510(k) preparation faster, clearer, and more defensible. We don't replace expert judgment; we give RA/QA professionals and founders credible starting points, structured comparisons, and exportable rationales to move from idea to submission with confidence.
Meet the Team
Olivia Charles
CEO/CRO
Bioethics, Business & Life Sciences; MHSc, University of Toronto.
Cole Connelly
CFO/COO
Cell & Molecular Biology and Immunology, University of Toronto.
Jonas Martins
CTO
Computer Engineering & AI, University of Toronto.
Maaz Ahmed
Tech Lead
MS in Software Engineering, Arizona State University.
Matthew Li
Full-stack Engineer
Computer Science & Business, University of Waterloo.
Pricing
| Plan | Price | Details |
|---|---|---|
| Alpha Preview | Free | Usage limits apply |
| Pro | Custom | Coming soon |
Transparent pricing will launch with general availability.
Frequently Asked Questions
Everything you need to know about Veridocx.
Still have questions?
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