Early-Stage Healthtech

Is my software a regulated device?

The question every early-stage healthtech founder asks eventually — usually later than they should. We help you find out before it costs you a funding round or a launch date, and map exactly what you need in place before either.

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Where we help

Device classification

A clear, defensible answer on whether — and how — your software qualifies as a medical device under EU MDR.

Funding-ready regulatory positioning

The regulatory story investors ask about, answered before they ask it.

What to build before market

A practical roadmap — QMS, technical documentation, cyber assurance — sequenced to your actual timeline, not a generic checklist.

Ready to find out where you stand?

No obligation, no generic sales process — just a direct conversation about your product.

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