Device Quality Ltd.

— About

Mark Kelleher. Principal Consultant.

Mark Kelleher, Principal Consultant
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

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