MED-DI-DIA LIMITED

MED‑DI‑DIA LIMITED is a Galway‑based regulatory consultancy that helps innovators bring medical devices, in‑vitro diagnostics and digital health solutions to market. Drawing on a strong scientific and technical background, the team provides end‑to‑end support for EU and US regulatory pathways, ensuring that products meet the latest requirements of the Medical Device Regulation, the In‑Vitro Diagnostic Regulation and FDA standards.

Their core services include acting as an EU Authorised Representative or Person Responsible for Regulatory Compliance (PRRC), delivering bespoke regulatory strategies for the EU, US and other global markets, and managing CE‑marking, technical file compilation and ISO 13485:2016 implementation. In the United States, MED‑DI‑DIA guides clients through 510(k), PMA and De Novo submissions, while also offering device classification, predicate‑device searches and assessments against the new EU regulations (including REGULATION (EU) 2023/607). The firm also supports companies navigating the EU Deforestation Regulation and provides fractional regulatory consultancy for organisations of any size, from start‑ups to multinationals.