Ontogen workspace

Medical-Device Regulatory Sandbox

Educational environment. Outputs are simulated planning hypotheses, not professional advice or agency decisions.

Configure a simulation

Define the product, jurisdiction, review board, and iteration rules.

01 · Intake

Proposal source

Start from a short concept or upload a prepared proposal.

Starting-point format

Clinical gap, direction, or device idea

Simulation settings

These settings shape classification and the review loop.

Jurisdiction

Maximum review rounds

Review stopping policy

Score-based stopping does not require agreement votes or a confidence threshold. Remaining findings are retained.

Pause between review rounds for optional user rebuttals

Simulated Review Board

Choose fixed stakeholder roles. Reviewers assess independently, then cross-talk and form issue-specific coalitions.

Board

Live multi-agent workflow

Follow delegation, evidence gathering, regulatory strategy, specialist review, and adjudication.

02 · Live process

Agent communications

Waiting for a simulation.

Review results will appear here

Start a simulation and wait for the first specialist board round to inspect scores, comments, source references, and rebuttal options.

No completed outcome yet

The final decision summary and downloadable dossier will appear here when the workflow completes or is stopped.