Ask the Expert: Safety and Performance Measures and Acceptance Criteria for IVDR

This session with President, Laurie Mitchell, and Principal Medical Writer, Dr. Sarah Chavez, answers questions regarding how to identify meaningful safety and performance measures or specify acceptance criteria in preparation for writing the SVR, CPR, and PER.  Watch the recording of this webinar by submitting the form.

 

Who should watch this session?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for IVDR submissions.

January 26th, 2022 11am PST | 2pm EST Virtual

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To watch the free Ask the Expert series recording, Safety and Performance Measures and Acceptance Criteria for IVDR, fill out the form below.

This session answers questions regarding:

  • How to identify meaningful safety and performance endpoints (measures/objectives)​
  • The best methods and practices for identifying the acceptance criteria for your IVD
  • Differences in processes for new devices versus established devices
  • and more...
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