QMS CONSULTANCY SERVICES LIMITED

QMS Consultancy Services Limited is a specialist consultancy dedicated to helping medical‑device entrepreneurs bring their innovations to market swiftly and compliantly. Led by Director Richard Hall, the firm combines deep regulatory expertise with a hands‑on, mentor‑style approach, offering a clear pathway through the complex landscape of medical‑device approval.

The core portfolio includes three flagship services. First, a free, weekly regulatory training programme delivered to accelerator hubs, universities and hospitals, where Richard personally coaches and mentors start‑ups on the nuances of device legislation. Second, a bespoke Quality Management System (QMS) built to ISO 13485:2016 standards – complete with over 50 procedures and associated forms – that can be fully operational within a week; to date the team has supported more than 85 successful Notified Body audits across ISO 13485, MDSAP, FDA and WHO frameworks. Third, the Technical File Template (TFT) streamlines the creation of a complete technical file, saving hundreds of hours and ensuring all regulatory requirements are met for approval.

With a reputation for turning regulatory challenges into opportunities, QMS Consultancy Services Limited is the go‑to partner for Irish and international medical‑device innovators seeking expert guidance, practical tools and a fast‑track to market.