Gain access to fractional regulatory and quality leadership from industry veterans. We provide strategic guidance on global market access, digital QMS transformation, and virtual manufacturing enablement, acting as an extension of your team to navigate complex compliance challenges.

Discover LENS, our AI-powered RegTech SaaS platform that turns complex regulatory intelligence into actionable insight. Streamline predicate searches, monitor post-market surveillance signals, and manage global registrations from a single, intuitive platform

Leverage our GPU-based hosting infrastructure, designed for the future of RegTech. We offer private, compliant hosting for LENS enterprise clients and decentralized compute services for data-intensive health-tech and AI research

SMEDTEC acts as both a UK Responsible Person (UKRP) and EU Authorised Representative (EU AR) for non-UK and non-EU manufacturers, managing regulatory compliance, device registration, and communication with authorities such as the MHRA and EU competent authorities. We ensure technical documentation, post-market obligations, and regulatory updates are maintained to keep products compliant and market-ready.