Ask the Expert: The Importance of Clinical Data

This session with President, Laurie Mitchell, and Principal Medical Writer, Dr. Sarah Chavez, answers questions regarding sources of data, literature searches, weighting & appraisal, and effective presentation in your CER or PER. 

 

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 or performance evaluation reports for EU MDR or IVDR submissions.

November 3rd, 2021 11am PST | 2pm EST Virtual

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To watch the free Ask the Expert series recording, The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER, fill out the form below.

This session answers questions regarding:

  • How to best collect and present data on similar (competitor) devices as well as data collection strategies for new products
  • Best practices for and examples of appraising literature and clinical data
  • Clarification between safety & performance metrics and risks & benefits analyses
  • and more...
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