Digital health and Software as a Medical Device (SaMD) companies routinely lose months, sometimes years, to regulatory activity that could have been anticipated during development rather than discovered afterward. This is rarely a failure of regulatory knowledge. It is a failure of sequencing — classification decisions made before the intended purpose is settled, evidence generated retrospectively to defend claims rather than to support them, and clinical or cybersecurity requirements surfacing for the first time at review, once the architecture that would satisfy them is already locked in.
Each step closes on a decision gate before the next begins.
MediLife Digital Health built its 10-Step Regulatory Pathway to correct that sequencing. It is not a compliance checklist — it is an operating model that keeps regulatory strategy, engineering delivery and evidence generation moving together, from the moment a product's intended purpose is defined through to its ongoing post-market lifecycle, across the UK, EU and US markets.
This paper introduces the pathway: its four phases — Define, Build, Approve and Sustain — the ten decision gates that structure it, the factors that determine how long any given product will take to reach market, and the single principle that underlies all of it — know the pathway before you build.
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