CASE STUDIES

Real regulatory work, real market outcomes.

Medtech teams use Formly to move from regulatory uncertainty to submission-ready evidence, certified products, and clearer launch paths across markets.

How coobi achieved CE marking in under six months

How coobi achieved CE marking in under six months.

Weeks to MDR certification: 8
Messages provided with experts: 175

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How MyoAct navigated FDA clearance for an AI-embedded SaMD

How MyoAct navigated FDA clearance for an AI-embedded SaMD.

Saved compared to alternative quotes: 70k€
Clinical trials needed: 0

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How LipoCheck brought an IVD to market across two regions simultaneously

How LipoCheck brought an IVD to market across two regions simultaneously.

Saved according to alternative quotes: 70k€
Weeks from 0 to registered device: 8

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