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UID:69da781214589@www.leap-up.com
DTSTAMP:20260411T183426Z
DTSTART:20261111T090000Z
DTEND:20261111T140000Z
SUMMARY:Medical device consultant training
DESCRIPTION:Training/workshop for medical device consultants (§83 MPDG)\nContents:\n\nEU legal system for medical devices and in-vitro diagnostics\nMedical Device Regulation (MDR) and InVitro Diagnostics Regulation\nMedical Devices Implementation Act (MPDG)\nMedical Devices Operator Ordinance (MPBetreibV)\nHow does a product become a medical device/in vitro diagnostic device?\nMedical Devices Consultant (MPDG)\nCooperation with the PRRC (MDR and IVDR)\nMarket surveillance/post-market surveillance (MDR and IVDR)\n\nShort biographies of the speakers:\nCornelius Weber is a trained healthcare and nursing professional and has successfully completed a bachelor's degree in medical technology. He is currently completing a distance learning programme in Regulatory Affairs at the Technical University of Lübeck. At the same time\, he is supporting the leap:up regulatory affairs team as a working student.\nKatja Krempler holds a doctorate in biology and has also completed the LifeScience Management course at ATV in Leipzig. She has many years of experience in quality management\, regulatory affairs and the authorisation of medical devices. After working as a regulatory manager and QMB in a Leipzig start-up\, she has been supporting start-ups and SMEs at leap:up since 2024 - focussing on quality management systems\, technical documentation and regulatory issues.
LOCATION:BIO CITY Leipzig\, Deutscher Platz 5\, 04103 Leipzig
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