Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, we will discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We will also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.

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.  

August 31st, 2022 Watch at a convenient time Recorded

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To watch the free webinar recording, Demonstration of Sufficient Clinical Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process, fill out the form below.


Takeaways from this session:

  • Determine which content applies to each classification
  • How to address data insufficiency for a WET or Legacy device
  • Outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device
  • And more!
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