Regulatory launch intelligence
Bring medical devices to market with confidence, across every jurisdiction.
GORA AI classifies your device, maps the regulatory pathway for each target market, and builds a traceable, review-ready dossier for your regulatory team to finalise — all from one controlled workspace.
One workspace · 16 regulatory markets
Why GORA AI
Replace scattered guidance with a structured decision system
GORA AI doesn't behave like a generic legal search engine. Every requirement it generates is traceable to the product attribute, rule, and source that triggered it.
Intelligent classification
Answer a short attribute questionnaire and GORA AI returns the device class and pathway for each market — with the exact rule that applies.
Global market map
Compare launch complexity, classification, and readiness side by side across 16 markets on one interactive map.
Dossier builder
Generate requirement checklists and controlled templates, track readiness, and export a regulatory strategy memo to PDF or Markdown.
GORA AI assistant
An in-workspace assistant surfaces evidence gaps, realistic timelines, and update alerts — answering only from curated regulatory source records.
Traceable evidence trail
Every requirement answers what is required, why, which attribute triggered it, and which authority or guidance supports it.
Source intelligence
Track regulatory changes by market with versioned sources and effective dates, so your strategy never runs on stale guidance.
How it works
From device to dossier in four steps
Select your device
Choose from the product catalogue or add a new device, then confirm its attributes.
Review the market map
See classification, pathway, and complexity for each target jurisdiction.
Build the dossier
Work the requirements checklist, open templates, and track readiness as you go.
Export & hand off
Export a strategy memo and follow deep links to official portals and registrations.
Global market map
One view of every market you want to enter
Stop juggling spreadsheets and consultant emails. GORA AI lays out classification, submission type, and readiness for each jurisdiction so you can prioritise launches by complexity and effort.
Join the waitlistDossier workspace
A controlled checklist, not a blank document
Each requirement comes with a template, a source citation, and a readiness state your team can own. Export the whole strategy as a PDF memo or copy it as Markdown in a click.
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Map your next launch today
Create a workspace in minutes and run your first device through the full classification and dossier workflow.