[FREE WEBINAR] IVD Deep Dive Series Part 1

Click here to watch the recording of this webinar.

In this webinar, we take a deep dive into the best practices to identify appropriate and relevant Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First, using a case study example, we discuss considerations and provide tips to help you select relevant Safety and Performance Objectives for your IVD. Next, we discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Finally we explain how these objectives help establish Acceptance Criteria, a critical input for establishing the SOA in your PER.

Key Takeaways

Based on the state of the art:​

  • Identify meaningful performance endpoints (measures/objectives)​
  • Demonstrate that performance objectives are appropriate and clinically relevant​
  • Specify acceptance criteria that are used to determine the acceptability of benefit-risk

Who Should Watch?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions, or anyone learning more about PER requirements.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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