Services
Everything you need to launch a regulated device
From first classification to submission handoff, GORA AI gives medtech teams a single controlled workspace for global regulatory strategy.
Device classification
Confirm a short set of product attributes and receive the device class and pathway for each market, mapped to the precise rule that applies.
- EU MDR Annex VIII rule logic
- FDA product code & pathway
- Risk-flag detection
Global market mapping
An interactive map of 16 markets with classification, submission type, and a complexity score so you can sequence launches by effort.
- 16 markets in one view
- Side-by-side market comparison
- Complexity scoring
Dossier builder
Turn requirements into an owned, trackable checklist. Each item carries a template, a source citation, and a readiness state.
- Requirements checklist
- Readiness scoring
- PDF & Markdown export
Controlled templates
A versioned template library for clinical evaluations, risk files, declarations and more — with document sign-off and a document repository.
- Versioned template outlines
- Document sign-off
- Document repository
GORA AI assistant
An in-workspace assistant that surfaces evidence gaps, estimates timelines, and flags updates — answering only from curated source records.
- Evidence-gap analysis
- Timeline estimation
- Source-cited responses
Source intelligence
Track regulatory change by market with versioned sources, effective dates, and update alerts so your strategy stays current.
- Versioned sources
- Effective-date tracking
- Update alerts
Who it's for
Built for the people who carry the launch
Regulatory affairs
Plan market-entry strategy and keep an auditable trail from attribute to requirement to source.
Founders & product
Test launch feasibility and compare market complexity before committing budget and timeline.
QA & consultants
Run multiple devices and clients from one workspace with consistent, defensible logic.
Coverage
16 markets, one workspace
Start now
Put your device on the map
Create a workspace and run your first classification and dossier in minutes.