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, submission-ready dossier — all from one controlled workspace.

EU MDRFDA / CDRHSwissmedic NMPAPMDA / MHLWANVISATGA
GORA AI — Launch Workspace
Device
PTCA balloon catheter
Readiness
72%
EU MDR
Class III · Rule 6
FDA pathway
510(k) · LOX
Dossier checklist
Clinical evaluation report
Risk management file (ISO 14971)
! Biocompatibility evidence — in review
! Swiss CH-REP appointment

One workspace · seven regulatory frameworks

EU MDR 2017/745FDA / CDRHSwissmedic China NMPAJapan PMDA / MHLWBrazil ANVISAAustralia TGA

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 seven jurisdictions 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

1

Select your device

Choose from the product catalogue or add a new device, then confirm its attributes.

2

Review the market map

See classification, pathway, and complexity for each target jurisdiction.

3

Build the dossier

Work the requirements checklist, open templates, and track readiness as you go.

4

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.

See it in your workspace
EU
European Union
EU MDR 2017/745 · Notified Body
Class III
US
United States
FDA / CDRH · 510(k)
Class II
CH
Switzerland
Swissmedic · CH-REP + swissdamed
CE-based
JP
Japan
PMDA / MHLW · Shonin
Class III
DOC
Clinical Evaluation Report
EU MDR Annex XIV
Ready
DOC
Risk Management File
ISO 14971
Ready
DOC
Biocompatibility Evidence
ISO 10993
In review
DOC
Declaration of Conformity
EU MDR Article 19
Not started

Dossier 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.

Browse all services
7Regulatory frameworks
100%Traceable requirements
4Steps to a dossier
1Controlled workspace

Get started

Map your next launch today

Create a workspace in minutes and run your first device through the full classification and dossier workflow.