[FREE WEBINAR] Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Click here to watch the recording of this webinar.

How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. 

Key Takeaways

  • How to address limited clinical and performance data
  • Learn how to adjust the Clinical Evaluation Plan to align with the regulatory strategy
  • Understand the concept of data sufficiency

Who Should Watch?

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.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

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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?

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[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

Spots are limited – click to register for this free webinar.

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