About

Why we built fsub?

Nobody starts a health tech company because they love regulation, but get it wrong and it costs you weeks, thousands of pounds, or your users' trust. fsub is the virtual regulatory consultant we wished we'd had: it works out what your product is, maps your route to market, and catches the wording that quietly moves your risk category, so you know where you stand before you build. Fast, clear, and priced for founders who don't have a compliance budget yet.

Who's behind it?

Two founders who've spent an unreasonable amount of their careers in regulated, safety-critical products, and somehow still find it interesting.

Linh (CEO) has spent years building health tech and launching SaMD tools under ISO 13485, 27001 and MDR, shipping regulated products across the US, UK and Asia, and holds strong opinions about building in medtech. Michael (CTO) comes from automotive cybersecurity (ISO 21434) and ISO 27001, and builds the quality infrastructure that keeps safety-critical products honest.

We work with health innovators through Imperial College Health Partners and build fsub alongside the founders using it, which is the only sensible way to make something people actually need.