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SAVE-THE-NEW DATES - IVDR & analytical performance testing requirements
"IVDR – State-of-the-art requirements for analytical performance testing"
„IVDR - Stand der Technik an analytische Leistungstests"
LISAvienna, BBMRI.at and en.co.tec will organize this virtual seminar with the goal to inform manufacturers and users of IVDs about these implications and to give insight into the current situation on the IVDR and related ISO standards and CEN Technical Specifications. Special emphasis will be put on the issues scientific validity and requirements for analytical performance testing, including pre-analytical requirements, and clinical performance testing.
Date: 21 Oct 2020 in context of the "LISAvienna - Regulatory Konferenz für Medizinprodukte und IVD" 20 Oct 2020
Time: 09:00-17:30 (tbc)
Location: Vienna, Austria
Target group: Employees of IVD-developers, IVD-users (incl. ISO 15189 accredited organizations)
Registration: NO registration fee, but registration required as number of participants is limited -
link will follow soon