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

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 Clinical Evaluation Report.  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 Clinical Evaluation Reports for MDR submissions.

February 9th, 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 MDR, 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 medical device
  • Clarification on the relationship between clinical benefits, risks, safety and performance endpoints, and acceptance criteria 
  • and more...
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