From Cork – Ireland
Lives in the Penedès region near Barcelona, Spain

Co-founder and Partner at Tecno-med Ingenieros S.L. (1995 – present).
Specialist in medical devices and medical technology regulatory affairs,
technical consultancy and quality management systems applied to medical
technology.

Academic Background: Degree in Electrical and Electronic Engineering B.E. (Elect.) from University College Cork UCC – National University of Ireland, Cork, 1991
Additional professional qualifications:
– Regulatory Affairs Professionals Society RAPS Member with RAC (devices) certification.
– American Society for Quality Certified Quality Auditor and Biomedical Auditor (ASQ CQA Biomed)
– Member of SEEIC – Spanish Society for Electromedicine and Clinical Engineering
– Member of the AENOR Subcommittee for Standardization in Electromedicine SC62/209
– Member of the AENOR Committee AEN CTN 111 – ISO 13485
– Lecturer at various higher-level education courses including “Quality Systems for the Manufacture of Medical Devices”, “Management and Maintenance of Clinical Equipment” and “Technologies for
Healthcare Evaluation” for Masters in Biomedical Engineering at the Polytechnical University of Catalonia and the University of Barcelona, 2007 – 2010 and “CE Marking and Medical Device Regulatory
Requirements” for Masters in Bio-nanotechnology at the Barcelona Autonomous University – 2008.
As a Member of the EAAR, close cooperation with association colleagues with specific professional interest and expertise in European medical device regulatory affairs, in particular in these years coinciding with the transition to the new MDR/IVDR regulatory regime, is being a very positive experience. In addition to specific mandated AR services, non-EU manufacturers of medical devices need accurate and timely information concerning applicable requirements from the specific European
perspective and from a reputable and reliable source of information. Liaison and close communication with the Commission, National Competent Authorities, Notified Bodies, and other industry stakeholders
are key to understanding these requirements and are valuable EAAR assets. As an EAAR Board Member, I actively support the EAAR to preserve these assets and strive to improve widespread understanding
of the EAAR role and obligations to promote safety and compliance of all medical devices placed on the EU market.