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RegReady.

Where your medical device sits under EU MDR and US FDA classification rules, across every class it could plausibly fall into, so you make that call deliberately rather than discover it late.

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Live

RegReady

Where your medical device sits under EU MDR and US FDA classification rules.

Your device class sets your route to market and your evidence burden long before you reach a Notified Body. RegReady shows you where your product sits under EU MDR and US FDA rules, across every class it could plausibly fall into, so you make that call deliberately rather than discover it late.

Built for medical device and diagnostic-software companies assessing EU and US entry. If your product is a therapeutic, a service, or not a regulated device, the Diagnostic is the better place to start.

WHAT YOU GET

MDR classification

Where your device sits under EU MDR Annex VIII, across Class I, IIa, IIb, and III, with the specific rule that drives it and the likelihood a Notified Body agrees.

FDA classification

The parallel US picture: your likely FDA class and pathway across 510(k), De Novo, and PMA, plus whether to sequence Europe or the US first.

What it means

What each classification changes commercially, from the evidence you must generate through to how investors read your file. Classification is a business decision, and this shows you the consequence of each route.

RegReady runs on the same regulatory classification engine HealthSeed uses in live MDR and IVDR client work.

GET YOUR CLASSIFICATION READ