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CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR

A session by Carolyn Guthrie
Director of QA/RA, Kapstone Medical

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About this session

This presentation will provide an overview of the technical documentation requirements under MDR including format and content. Changes from MDD will be highlighted throughout the presentation, as well as any differences in content or level of detail required based on device classification. A brief overview of the application and review process with the Notified Body will also be provided, as well as provide insight into other requirements that will be used to support the submission (including CER, PMS and PMCF).

Presentation Take-aways:

  • Understand technical documentation requirements under MDR
  • Understand the submission and review process with the Notified Body
  • Understand the relationship between Technical - - Documentation and other supporting documentation.

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