MedTech / Digital Health

Regulatory intake

Answer the questions below as honestly as you can. The decision engine weighs intended use, claims, and evidence — not marketing framing — to return a regulatory snapshot.

Load demo scenario

One-click presets for live demos and workshop sessions.

Product

The basic shape of what you are building.

Product name

Short product description

Intended user

Intended use

Markets

Where you intend to launch first.

Function and clinical role

The decision engine treats these as primary classification triggers.

Is software involved?

Does it influence treatment decisions?

Does it connect to hardware?

Does it process patient data?

Does it use AI/ML?

Clinical functions

Select all that apply. These are the strongest signal of medical device intent.

Claims and evidence

Claims framing — not just function — drives regulatory status.

What claims are being made?

What evidence exists today?

Stage and uncertainty

Stage

Biggest regulatory uncertainty

Required: product name, intended use, at least one market.