Ask the Expert: Safety and Performance Measures and Acceptance Criteria

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 for the clinical evaluation or performance evaluation. 

 

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 17th, 2021 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, fill out the form below.

This session answers questions regarding:

  • How to identify meaningful safety and performance endpoints
  • How to demonstrate that safety and performance endpoints are appropriate and clinically relevant
  • The biggest pitfalls to watch out for when identifying safety and performance measures
  • and more...
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