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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

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

Profile

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

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

    11:50am
  • Multi-Stakeholder Panel: Dealing with Capacity Concerns

    4:10pm