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MedTech Summit


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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Tommy McDonagh
Associate Director Regulatory Affairs (IVDR) at Abbott Core Diagnostics


Tommy McDonagh is an Associate Director of Regulatory Affairs, IVDR at Abbott Core Diagnostics (based in Sligo Ireland).

Tommy joined Abbott in April 2005 and has held multiple roles across Quality, Technical Operations and Regulatory. In his current role he leads the IVDR transition Program for the European Manufacturing sites across a broad portfolio of products across all IVDR product classifications.

As part of his role, he interfaces with various regulatory bodies, including Notified Bodies and multiple Competent Authorities. Tommy is an active member of the Irish Medtech Association (IMA) IVD Task Force supporting the IMA QARA Forum and a member of the IMA Regulatory Steering Committee.

Tommy holds a Master’s degree in Biomedical Science from the University of Ulster – Coleraine in Northern Ireland and a Bachelor of Science in Microbiology from the University of Galway, Ireland. He also holds a Project Management Professional (PMP) certification.

Agenda Sessions

  • Class D The Latest News: Conformity Assessments and Common Specifications