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MedTech Summit US
November 14 - 16, 2023
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Sean O'Callaghan
Senior Scientific Officer-Certification & Inspection, Medical Devices at National Standards Authority of Ireland (NSAI)


Seán O’Callaghan is a certification and inspection officer with the NSAI. He performs ISO 13485 site audits and is a product reviewer of Technical Documentation under the MDD, IVDD, and MDR.

His background is predominantly in In Vitro Diagnostics, and he is a member of the NSAI’s IVDR Designation Team.

Agenda Sessions

  • Accuracy of Wording: Reading the Regulation to Build a Technical File Reflective of your Product and How to Avoid Pitfalls of Terminology

  • Notified Body Feedback: Identifying and Demonstrating Intended Purpose under MDR and IVDR

  • Multi-Stakeholder Panel: Dealing with Capacity Concerns