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UID:3375-1650452400-1650456000@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally\, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example\, the SLR approach\, data screening\, and data presentation will be addressed. \nYou will learn:\n\nThe importance of the SOA SLR for providing background and general information\nHow to establish acceptance criteria with data\nHow to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process\n\nWho should attend?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. Also\, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend. \nClick here to watch the webinar recording. \nIVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\nHow can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER\, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist\, we will walk through the necessary documents\, SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nThis presentation will emphasize the importance of scoping\, discuss how to develop a checklist\, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process. \nWatch the free webinar recording now.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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