Webinar

CER Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to defining the key foundational concepts of the Clinical Evaluation Report (CER). Learn how to effectively identify, present, and analyze the parameters of safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratios within the context of an MDR-compliant CER. 

Who is this webinar for? 

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.

September 28, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, CER Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis, fill out the form below.

 

Takeaways from this session:

  • Define the key foundational CER concepts and their relationship to each other 
  • Learn how to develop MDR-aligned safety and performance objectives
  • Understand how clinical outcomes are leveraged in the CER and how they are different from S&P objectives
  • And more!
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