agenda

  • 09:00 AM: Get Together

  • 09:30 AM: Welcome
    Jens Fröhlich, oxaion gmbh

  • 09:45 AM: Introduction of oxaion and Aptean in medical technology
    Jens Fröhlich, oxaion gmbh

  • 10:00 AM: A look into the MTC - Medical Technology Cluster Upper Austria - The role of the cluster, support for companies, start-up support and networking
    DI (FH) Martha Wagner, MTC Business Upper Austria, OÖ Wirtschaftsagentur GmbH

  • 10:20 AM: MDR Regulatory Update: The transition to the MDR/IVDR "Good things take time?" An overview of the most important developments (transition periods, notified bodies, EUDAMED) that you should definitely know
    Martin Schmid, en.co.tec Schmid KG

  • 11:15 AM: Coffee break

  • 11:30 AM: Fundamentals of the Unique Device Identification System (UDI) for medical devices. General overview of UDI, Basic UDI-DI (BUDI), Label/Carrier/Issuing Entities, rules for specific devices, treatment unit according to Article 22, EUDAMED, Why is the NB interested?
    Daniel Rubisoier Bsc, MSc, TÜV SÜD Product Service GmbH

  • 12:15 PM: Lunch

  • 1:00 PM: oxaion easy Medical Technology - The business software for small medical technology companies - Presentation of the concept with validation documentation
    Jens Fröhlich, oxaion gmbh

  • 1:30 PM: MBA Health Tech Management - Presentation of the new Master's program at the University of Applied Sciences Technikum in Vienna
    Matthias Scherer, FH Technikum Wien

  • 2:00 PM: UDI in business software & change management with ERP
    Sven Hertel, oxaion

  • 2:30 PM: Exchange of experiences on regulatory requirements from the MDR
    Daniel Rubisoier BSc, MSc, TÜV SÜD Product Service GmbH

  • 3:00 PM: Guided tour of ARS Electronica

  • 4:00 PM: End

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