| BBMRI.at, en.co.tec and LISAvienna are jointly organizing the fourth conference on the regulatory requirements for the market approval of medical devices and in-vitro diagnostics in Europe. Use this free opportunity to update your knowledge and strengthen your network!
For the first time, the event will take place online and over two days. Lectures and discussions on the subject of medical devices and MDR are planned for October 20, while October 21 is entirely dedicated to the subject of in-vitro diagnostics and IVDR.
We are pleased that numerous experts from all relevant areas are taking part in the program, including several European notified bodies.
We invite you to secure a place on the participation list now. The details of the program will follow in the coming weeks. A few days before the event registered participants will receive a participation link from LISAvienna. REGISTER NOW! Registration >> Announcement Flyer >> Some planned topics: - Scientific and medical relevance of standard in diagnostics
- Importance of pre-analytical ISO and CEN standards an IVD manufacturer's perspective
- Development of European and international standards for pre-analytics
- Standards and the IVDR
- Performance evaluation test according to VO (EU) 2017/746 - what does the notified body test?
- Regulatory requirements for performance studies by the IVDR
- Performance evaluation of IVDs under EU regulation 2017/746
- Theory meets practice: pre-analytics standards in routine molecular pathology diagnostics
- Performance evaluation tests according to IVDR in laboratory diagnostics
Planned speakers & panelists:
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Ecker Wolfgang, MinR iR Hon(FH)Prof. Dr.; FH Medizintechnik Linz, FH Technikum Wien, Wien, Österreich -
Halwachs Peter, DI; LISAvienna, Wien, Österreich -
Harer Johann, DI Dr.; Human technology Styria GmbH (HTS), Graz, Österreich -
Kashofer Karl, PD Mag. Dr. phil.; Medizinische Universität Graz, Diagnostik und Forschungsinstitut für Pathologie, Graz, Österreich -
Möhlig-Zuttermeister Heike, Dr.; BSI Group Deutschland GmbH, Frankfurt, Deutschland) -
Oelmüller Uwe, Dr.; QIAGEN GmbH, Hilden, Deutschland und PreAnalytiX GmbH, Hombrechtikon, Schweiz; ISO/TC 212 und CEN/TC 140 WG Convenor sowie Koordinator des H2020 Projektes SPIDIA4P (www.spidia.eu) -
Pölzleitner Michael, DI; mdc medical device certification GmbH, Zweigniederlassung austria, Wien, Österreich; Austrian Standards International - Vorsitzender K179 Medizinprodukte -
Schmid Martin, DI; en.co.tec Schmid KG, Wien, Österreich -
Schröder Ulrike, M.Sc.; Deutsches Institut für Normung e. V. (DIN), Berlin, Deutschland -
Herrmann Markus, Prof. Dr. Klinisches Institut für Medizinische und Chemische Labordiagnostik -
Serafimovic Nebojsa, BSc;, BASG - Bundesamt für Sicherheit im Gesundheitswesen, AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit, Wien, Österreich -
Zatloukal Kurt, Univ.-Prof. Dr.; Medizinische Universität Graz, Diagnostik und Forschungsinstitut für Pathologie, Graz, Österreich; BBMRI.at - Direktor des Österreich-Knotens der europäischen Biobanken Forschungsinfrastruktur BBMRI-ERIC Conference language: German | |  |
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