program

  • 09:00 AM: Get Together

  • 09:30 AM: Welcome & Short presentation of Aptean DACH GmbH
    Jens Fröhlich, oxaion gmbh / Aptean DACH GmbH

  • 09:45 AM: oxaion Business Software – Overview
    Sven Hertel, oxaion gmbh / Aptean DACH GmbH

  • 10:15 AM: Coffee Break

  • 10:30 AM: Theory & Practice: How digitalization helps to optimize processes and comply with regulations – using the example of Inpac Medizintechnik GmbH
    Jens Fröhlich, oxaion gmbh / Aptean DACH GmbH

  • 11:15 AM: Fundamentals of "Unique Device Identification (UDI) for Medical Devices": UDI System (UDI-DI & UDI PI, AIDC formats, UDID), BASIC UDI-DI, Rules for special medical devices, Implementing UDI in the QMS
    Daniel Rubisoier, Regulatory Affairs Specialist, TÜV SÜD Product Service GmbH

  • 12:00 PM: Unique Device Identification – UDI in Practice
    Sven Hertel / Jens Fröhlich, oxaion gmbh / Aptean DACH GmbH

  • 12:30 PM: Lunch Break

  • 01:15 PM: MDR/IVDR – The main challenges for economic operators and where there are still open issues
    Martin Schmid, encotec GmbH

  • 02:00 PM: Medical Technology Functions in Business Software
    Sven Hertel / Jens Fröhlich, oxaion gmbh / Aptean DACH GmbH

  • 02:45 PM: Departure to Bergisel

  • 03:00 PM: Guided tour of the Bergisel Ski Jump
    Karin Bärmann, oxaion gmbh / Aptean DACH GmbH

  • 04:00 PM: Coffee and closing remarks at the Sky Restaurant

  • From approx. 04:30 PM: Return journey

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