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UID:69e4c84259b70@leapup.bitshifters.cloud
DTSTAMP:20260419T141914Z
DTSTART:20210615T080000Z
DTEND:20210615T120000Z
SUMMARY:MDR (EU 2017/745) impact on QMS
DESCRIPTION:Training objectives:The following skills and competencies are developed:\n\nUnderstanding the EU regulation for medical devices\nIdentifying applicable MDR requirements and the impact on the QMS\n\nTraining content:\n\nRegistration of economic operators &amp\; their obligations\nRegistration of devices\nNew product classification and conformity assessment procedures\nReview and definition of changes / new requirements regarding QMS\, in particular:\n\n\nCommunication with stakeholders\nStrategy for regulatory compliance\nPerson responsible for regulatory compliance\nSufficient financial liability\nRisk management process\nClinical evaluation and investigation process\nVigilance and PMS process\nUDI\, labelling and EUDAMED\nTechnical documentation structure\n\n&bull\; Importance of transition timeline
LOCATION:Online\, Lausanne
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