Device Quality Ltd

Device Quality Limited is a specialist medical device quality and regulatory consultancy based in Kilkenny, Ireland, established in 2018. The company provides expertise in ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820, serving startups and scale-ups in the medical device sector. Its services include quality management system development, FDA submissions, CE marking, risk management, and post-market surveillance. The firm also offers outsourced Management Representative and Person Responsible for Regulatory Compliance roles under ISO 13485 and EU MDR, as well as fractional QA/RA executive leadership on a part-time basis. With over 18 years of experience building quality systems, the company works directly with a senior principal consultant, avoiding junior hand-offs. It supports clients across Ireland, including Galway, Dublin, Cork, Tipperary, and Wexford, with a focus on active implantable, cardiovascular, and neuromodulation devices.