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UID:69e8a2c55d6eb@leapup.bitshifters.cloud
DTSTAMP:20260422T122821Z
DTSTART:20210629T090000Z
DTEND:20210629T120000Z
SUMMARY:IVDR Overview
DESCRIPTION:Training objectives:The following skills and competencies are developed:\n\nOverview of IVDR challenges compared to existing IVDD\nBetter understand the risk-benefit ratio approach\nIdentify applicable IVDR requirements and the impact on the quality management system\nIdentify applicable IVDR requirements and the impact on the technical file\nPlanning of Verification &amp\; Validation under IVDR\n\nTraining content:\n\nIVDR structure and definitions\nKey changes under IVDR and risk-benefit ratio approach\nTransition timelines\nNew Classification rules\nStructure of the Technical Documentation\nGeneral Safety and Performance Requirements (GSPR)\, what&rsquo\;s new?\nAdditional requirements on:\n\n\nClinical Evidence and Performance Evaluation Report\nPost Market Surveillance\nConformity Assessment\n
LOCATION:Online\, Lausanne
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