BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//YourOrganization//EventDownload//DE
CALSCALE:GREGORIAN
METHOD:PUBLISH
BEGIN:VEVENT
UID:6a05ac0813992@www.leap-up.com
DTSTAMP:20260514T130336Z
DTSTART:20251127T130000
DTEND:20251127T150000
SUMMARY:Workshop: Crash course MDR/IVDR
DESCRIPTION:Content:\n\nThe regulation and the basic principles\nEconomic operators\nAnnex I: General safety and performance requirements - Selection of harmonised standards\nQuality management system\nAnnex II/III: Requirements for the content and scope of technical documentation\nClinical evaluation\nPost-market surveillance (PMS)\nMedical Device Regulation and reporting obligations\; labelling\, traceability (UDI\, EUDAMED)\n\nShort biography of the speaker:\nKatja Krempler holds a doctorate in biology and 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 in the areas of quality management systems\, technical documentation and regulatory issues at leap:up since 2024.\nCosts:\n\n€50 for biosaxony members\n€100 for non-members\n\nThe workshop will be held in English.\nRegister now and send an email to katja.krempler@leap-up.com!
LOCATION:leap:up GmbH\, Deutscher Platz 5\, 04103 Leipzig
END:VEVENT
END:VCALENDAR