who we are

mARK kELLEHER

Owner and Principal Consultant at Device Quality Ltd.

Experience

Mark is a highly qualified Principal Quality Consultant with over twenty-six years’ experience in multinational and start-up companies, including fourteen years in Medical Devices. He has an exceptional record of project delivery in roles with significant responsibility, working with a broad range of medical device 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 is a former chair of the Biomedical Engineering Division of Engineers Ireland.

Core Competencies

Device Quality Limited specialises in the implementation of ISO 13485:2016/ MDR / FDA-compliant Quality Management Systems for clients in the medical device industry.

Core Competencies include:

QMS Development
Risk Management
Design Controls
Internal Audit Programme
Supplier Management
Notified Body Audits
Product Testing