In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).
Understand the required and critical content common to both documents
Learn best-practice writing strategies to support successful completion of these challenging projects
Who Should Watch?
Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services | Criterion Edge
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