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PDF Download | Analytical and Clinical Performance for IVDs

In-vitro diagnostics can appear to be even more challenging than “rocket science”, but the reality is that we just need good science. This webinar, hosted by Diane M. Ward and Weiwei Wang will explore the tools of design control, as well as touches on how we use good science before we step into the lab to lay out what the design needs to achieve given the intended use we want to claim. 

In this webinar, you will learn ways to:

  • Use the design control elements to help them organize and manage the work that needs to be done to develop an IVD product. 
  • Understand how the analytical studies are related to the accuracy claim for the product.
  • Use the required accuracy for the product to determine the acceptance criteria for the analytical studies.

Download the presentation below or watch the webinar On-Demand

Diane M. Ward, PhD
Weiwei Wang, PhD/MSc
Date d'envoi: septembre 22, 2023
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