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Your 510(k) Strategy,
Built on Evidence.

Stop guessing which predicates to cite. Veridocx analyzes 180,000+ cleared devices to surface the strongest matches—with complete FDA citations and audit-ready documentation.

180,000+ cleared devices7,042 product codesWeekly FDA sync
app.veridocx.ai/dashboard
Veridocx dashboard showing device classification and predicate analysis

Supported by leading programs

Toronto Metropolitan University University of Toronto ChaiTech Accelerator Innovation Booster Zone (TMU) Brampton Venture Zone (TMU) Social Ventures Zone Toronto Metropolitan University University of Toronto ChaiTech Accelerator Innovation Booster Zone (TMU) Brampton Venture Zone (TMU) Social Ventures Zone
Regulatory Bottleneck

The 510(k) Problem: predictable work, high stakes.

The average 510(k) submission takes 6-12 months and costs $31,000+ in regulatory consulting fees.

Most of that time isn't spent on strategy. It's spent on systematic research—searching 180,000+ cleared devices, comparing specifications, and mapping standards.

Work that's predictable. Tedious. And ripe for automation.

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Average 510(k) timeline (months)
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Typical consulting fees
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Time spent on systematic research
Product Core

Automated SE Matrix Generation

The Substantial Equivalence (SE) matrix is the heart of your 510(k). Veridocx automates the comparison across indications, technological characteristics, and performance specifications—grounded in complete FDA citations.

Instant Comparison

Compare indications and tech specs in seconds, not days.

FDA Citations

Every data point is linked directly to the source FDA summary.

eSTAR Compatible

Export tables directly into your FDA submission templates.

Explore Full Workflow
app.veridocx.ai/matrix
Veridocx SE Matrix showing automated device comparison
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product codes analyzed instantly
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predicates searchable in seconds
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traceable to FDA sources
Weekly
updated from FDA databases
Methodology

Built for Regulatory Rigor

Regulatory professionals need evidence, not black-box AI. Veridocx is engineered to meet the same standards of rigor your team applies to every FDA submission.

Learn about our methodology

Already have an eSTAR builder?

Great. Use Veridocx first.

What You NeedSubmission ToolsVeridocx
Find optimal predicates
Manual search
AI-ranked
Generate SE comparison
Write yourself
Automated
Identify testing gaps
Not offered
With standards
Fill eSTAR form
Core feature
Coming soon

Simple Pricing

Get started free during early access. Professional plans available for teams.

Early Access

Full platform access

Free

No credit card required

  • Complete 510(k) workflow (all 5 steps)
  • Access to 180,000+ 510(k) database
  • Gap analysis with standards mapping
  • Export in PDF, DOCX, CSV

Professional

For RA teams and consultants

Contact Us

Custom pricing for your team

  • Everything in Early Access
  • Unlimited projects
  • Priority support
  • Team workspaces with RBAC
  • API access

Need custom deployment or compliance requirements?
Contact us for enterprise options

Ready to accelerate your 510(k) workflow?

Join regulatory teams already using Veridocx to streamline predicate research and gap analysis.

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