Regulation
The EU AI Act meets MDR: what AIaMD teams must do now
How the AI Act layers onto MDR for AI-based medical devices — and the documentation to start building today.
Stefani founded Meridian 103.8 to give medical technology teams one senior partner across the whole route to market — from regulatory strategy and quality systems to commercial scale and capital.
Stefani leads regulatory strategy and the overall engagement across EU MDR, US FDA and Singapore HSA for device, SaMD and AIaMD programmes.
Her work starts before the first submission: defining the product, its intended purpose and its regulator-ready pathway so that evidence, quality systems and documentation are built once and reused across markets. That means fewer surprises at audit, shorter review cycles, and a clinical evidence package that also answers the questions payers and investors ask.
She works hands-on with founders and regulatory leads — writing and reviewing technical documentation, preparing teams for notified body and FDA interactions, and sequencing the work so runway is spent in the right order. For AI-based devices she focuses on the overlap between MDR and the EU AI Act, where most teams underestimate the documentation burden.
Beyond clearance, Stefani connects approval to traction: positioning, reimbursement pathways, investor readiness and non-dilutive grant funding across Europe, the USA and Singapore.
EU MDR / IVDR, US FDA, Singapore HSA — mapped in parallel, not sequentially.
SaMD and AI as a Medical Device, clinical evidence strategy, QMS and technical documentation.
First-in-class start-ups through scale-ups preparing to raise or exit.
United Kingdom, working across the UK, EU, US, Ireland and Singapore.
How the AI Act layers onto MDR for AI-based medical devices — and the documentation to start building today.
A practical framework for structuring evidence once and reusing it across MDR, FDA and HSA submissions.
The European and Singaporean funding programmes that extend runway before you give away equity.
Tell her where you are on the journey — development, compliance, scale or capital — and she’ll map the path from here.