— About
Mark Kelleher. Principal Consultant.

Mark is a Principal Consultant and 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 eighteen 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.
— Experience
Eighteen years in medical devices.
Active implantable
Class III devices for long-term implantation
Cardiovascular
From catheter-based to structural heart
Neuromodulation
Implantable neurostimulation systems
Quality systems
Built from scratch and remediated at scale
— Credentials
Academic and professional.
- BEElectrical & Electronic Engineering · University College Cork
- MEngScEngineering Management · University College Dublin
- PgDipRegulatory Affairs · Trinity College Dublin
- MemberRegulatory Affairs Professional Society (RAPS)
- Former ChairBiomedical Engineering Division · Engineers Ireland