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SAVE-THE-DATE - IVDR & analytical performance testing requirements

SAVE-THE-DATE

 

"IVDR – State-of-the-art requirements for analytical performance testing"

 

LISAvienna and BBMRI.at will organize this event 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: 20 Oct 2020 (in context of the "LISAvienna - Regulatory Konferenz für Medizinprodukte und IVD")

 

Time: 09:00-17:30 (tbc)

 

Location: Vienna, Austria

 

Organizers:

 

 

Target group: Employees of IVD-developers, IVD-users (incl. ISO 15189 accredited organizations)

 

Aims:

  • Raise awareness for pre-analytical standards as state –of-the-art for selected molecular analyses

  • Inform about relevance of pre-analytics and corresponding standards in the context of IVDR (incl. lab developed test

               

Speakers from

  • European Committee for Standardization (CEN)

  • Austrian Standard International (ASI)

  • QMD Service GmbH (applied for Austrian Notified Body)

  • LISAvienna

  • QIAGEN GmbH

  • Analytical performance testing from a users' perspectives (e.g. pathology, clinical lab)

  • BBMRI.at

  • Panel Discussion: Questions & answers with all speakers and selected invited persons representing the Austrian Cluster and Network initiatives e.g. Human technology Styria

  • Organizers: LISAvienna and BBMRI.at

 

Language: German