November 14 - 16, 2023
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota Sean O'CallaghanSenior 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
Accuracy of Wording: Reading the Regulation to Build a Technical File Reflective of your Product and How to Avoid Pitfalls of Terminology
, 10:05amView SessionNotified Body Feedback: Identifying and Demonstrating Intended Purpose under MDR and IVDR
, 12:10pmView SessionMulti-Stakeholder Panel: Dealing with Capacity Concerns
, 3:45pmView Session