who we are

Mark Kelleher

Owner and Principal Consultant at Device Quality Ltd.

Experience

Mark is a Principal Consultant ans owner at Device Quality Limited. He has over twenty-six years’ experience across multinational corporations and medical device startups — and it’s in the startup world where he thrives. With eightten years focused on medical devices, he brings hands-on expertise that early-stage companies need: building quality systems from the ground up, navigating regulatory hurdles fast, and delivering results without the overhead of a large team.


His background spans a broad range of technologies, including active implantable, cardiovascular, and neuromodulation devices.
Mark holds a Bachelor’s degree in Electrical and Electronic Engineering from University College Cork, a Master’s degree in Engineering Management from University College Dublin, and a Postgraduate Diploma in Regulatory Affairs from Trinity College Dublin. He is a member of the Regulatory Affairs Professional Society and is a former Chair of the Biomedical Engineering Division of Engineers Ireland.