GreenLight OSMedical Device Licensing
Sign in/up
GreenLight OS · Medical Device LicensingCanada & US

Avoid a costly rejection.

Get the correct class and pathway for Canada & the US — with full rule citations and bilingual rationale.

Start 3 Free Classifications
EXAMPLE · US 510(k)

Device Classification Report

Report generated on 10/31/2025

Pulse Oximeter (Non-Invasive Monitoring)

Device Class
Class II (US)
Estimated Gov. Cost
≈ USD 19,870
510(k) submission fee as of 2025. Excludes testing or consulting.
Regulatory Pathway
510(k) Premarket Notification
Substantial equivalence to a predicate device.
Timeline (estimate)
3–6 months
Typical review window; may vary by submission quality.
Risk Score
7 / 17 · Moderate
Higher score indicates higher inherent risk.
Description
Substantial equivalence to a predicate device is required. The full report shows the reasoning chain with 21 CFR citations.
Classification confidence: 95%

Aligned with International Standards

US FDA LogoU.S. FDA
Health Canada LogoHealth Canada
ISO 13485 LogoISO 13485
IEC 60601 LogoIEC 60601

Why GreenLight OS works differently

Traditional RA/QA work relies on individual expertise and scattered documents. GreenLight OS turns that into a structured, traceable decision process with rules, rationale, and bilingual explanations.

Traditional RA/QA

  • Search through dozens of regulations

  • Reasoning lives in head/slides

  • Cost/timeline unclear

With GreenLight OS

  • One-to-one questions mapped to rules

  • Full reasoning chain ready to export

  • Clear timelines & fees upfront

How it works

GreenLight OS doesn't replace your judgment. Instead, it makes the regulatory logic transparent, structured, and repeatable—so you can explain every decision to auditors, partners, and your own team.

1

Answer structured questions

Decision tree based on rules.

2

Get classification + pathway

Engine determines Class & License type.

3

Review bilingual rationale & export

Audit-ready PDF.

Frequently Asked Questions