Expert consultancy.
Intelligent platforms.
A complete ecosystem of services and technology designed to work as one — from embedded regulatory leadership across devices, IVDs and cosmetics to AI-powered platforms and bespoke compliance tools.
Fractional regulatory and quality leadership, embedded RA/QA roles, and strategic guidance from submission strategy to post-market surveillance — across medical devices, IVDs and cosmetics, including borderline products. EU MDR, IVDR, FDA, MHRA — we've done it.
UK Responsible Person (UKRP) and EU Authorised Representative (EU AR) services. We act as your official representative — managing MHRA and EU competent authority obligations so you can focus on building.
Our AI-powered regulatory operations platform — giving regulatory teams the tools to work smarter, move faster, and stay audit-ready at every stage.
Bespoke compliance tools built on your own infrastructure, with your own IP — custom AI integrations, compliance operations and supply-chain optimisation. Where SMEDTEC OS is our platform, Compliance Studio is yours, engineered around you.
Meet SMEDTEC OS
Born from years of regulatory practice, SMEDTEC OS is our standalone SaaS platform for medical device regulatory teams. Manage submissions, registrations, document control, and compliance workflows in one auditable, AI-enhanced platform.
Visit SMEDTEC OS →
Meet Compliance Studio
Some teams want a platform; others want compliance engineered into their own systems. Compliance Studio builds bespoke tools, AI integrations and operational workflows on your infrastructure — your IP, your stack, our regulatory and engineering expertise.
Explore Compliance Studio →Trusted by innovators
across health-tech
A selection of companies we’ve helped navigate the regulatory landscape across EU, UK, and US markets.