KEANE MEDTECH LIMITED

Keane MedTech is a specialist consultancy dedicated to helping medical‑device companies achieve and maintain European regulatory compliance. Backed by more than two decades of industry experience, the firm offers end‑to‑end quality and regulatory support for devices of every class, working with start‑ups, SMEs and multinational manufacturers alike.

Their core services include comprehensive audit support—ranging from internal audit programmes and mock audits to remediation after Notified Body findings—and the optimisation of Corrective and Preventive Action (CAPA) processes. Keane MedTech also crafts bespoke regulatory strategies, liaising with European authorities to secure clear pathways to market. In addition, the team provides proactive post‑market surveillance, incident investigation and field‑safety corrective actions, as well as expert guidance on MDR economic‑operator responsibilities and the development of robust Quality Management Systems.

Led by Principal Consultant and Director Orla Keane, the consultancy combines deep technical knowledge with a pragmatic, client‑focused approach, ensuring that every project—whether a single engagement or a long‑term partnership—delivers the compliance and quality outcomes required for success in the European medical‑device landscape.