Ask the Writers: A Comparison of Critical Elements of the SVR versus the CER State-of-the-Art and Best Practice Writing Strategies

This session, hosted by Laurie Mitchell and Dr. Sarah Chavez, outlines 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). Learn best practice writing strategies and the critical content needed for successful completion of these projects.

Who should watch this session?

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.

May 18th, 2022 Watch at a convenient time Virtual

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This session answers questions like:

  • At what stage of product development should the SOA be established and written?
  • Being new to the industry, what is the best approach to take when writing a CER?
  • What strategy would work best for legacy, wet, low risk devices?
  • and more...
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