From Design to Global Sales — One Platform for Medical Device Market Access

Stop guessing if your device will be approved. Start planning how it will sell — in the US, Canada, EU, China, and beyond — from day one.

Get Started Free — 3 Simulations →⚡ Watch How a MedTech CEO Cut Time-to-Market by 70%

You didn't build a medical device just to get a 510(k) number.

You built it to save lives — and grow your business.

But every time you add a feature, change a material, or target a new market... You risk:

A costly RTA rejection
A 6-month delay
A distributor refusing to carry your product
A regulatory surprise that forces a redesign

Greenlight OS is not a submission tool.

It's your Market Access Operating System — engineered for manufacturers who want to:

Design with compliance in mind — before you spend a dollar on prototyping
Submit with confidence — with AI-generated RTA-proof documentation
Expand globally — see exactly what's required for Canada, EU MDR, or China NMPA
Trust your distributors — with real-time license verification via DockProof

How It Works

1

Answer Simple Questions

Our guided questionnaire helps you describe your device quickly and accurately.

2

See the Logic Build

Watch as our AI-powered engine applies regulatory rules and case-based reasoning.

3

Get Your Report

Receive instant classification, pathway determination, and documentation requirements.

Our Services

Everything you need to navigate medical device regulations in the US and Canada.

3 Free Uses

Classification Tool

Get instant regulatory classification for your medical device in the US or Canada.

  • 3 free uses for new users
  • Guided questionnaire
  • AI-powered classification
  • Instant results
  • Unlimited with Basic subscription
Try Free Tool
Monthly Subscription

Basic

Unlimited access to the classification tool plus automatic report saving with timestamps.

  • 10 times per month
  • Automatic report storage
  • Timestamp tracking
  • Easy report retrieval
  • Historical comparison
Subscribe Now

Create a free account to save your reports

Never lose your classification work again. Sign up to automatically save all your reports with timestamps and access them from anywhere.

Get Started Free

Built for Regulatory Professionals

Everything you need to navigate medical device regulations with confidence.

Regulation-Cited Logic

Every classification decision shows the exact regulatory rule that applies.

Instant Reports

Download PDF reports with all citations and regulatory references included.

US & Canada Coverage

Navigate both FDA and Health Canada requirements in one platform.

Traceable Reasoning

See the complete audit trail from your answers to the final classification.

Bilingual Support

Full interface and regulatory guidance available in English and Chinese.

Try It Free

Select Your Jurisdiction

Free trials remaining: 0 of 2

Register to continue your licensing journey.

United States

FDA Medical Device Classification

Canada

Health Canada Medical Device Classification

Frequently Asked Questions

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