Services
From first classification to submission handoff, GORA AI gives medtech teams a single controlled workspace for global regulatory strategy.
Confirm a short set of product attributes and receive the device class and pathway for each market, mapped to the precise rule that applies.
An interactive map of seven jurisdictions with classification, submission type, and a complexity score so you can sequence launches by effort.
Turn requirements into an owned, trackable checklist. Each item carries a template, a source citation, and a readiness state.
A versioned template library for clinical evaluations, risk files, declarations and more — with digital signature and document repository.
An in-workspace assistant that surfaces evidence gaps, estimates timelines, and flags updates — answering only from curated source records.
Track regulatory change by market with versioned sources, effective dates, and update alerts so your strategy stays current.
Who it's for
Plan market-entry strategy and keep an auditable trail from attribute to requirement to source.
Test launch feasibility and compare market complexity before committing budget and timeline.
Run multiple devices and clients from one workspace with consistent, defensible logic.
Coverage
Start now
Create a workspace and run your first classification and dossier in minutes.