Description: State Of The Art (SOTA) is an IVD-R mandatory element of the Performance Evaluation of each IVD device. Manufacturers must have a clearunderstanding of what SOTA is and on how it can be adequately documented. This involves Common Specifications, Standards and, when neither areavailable, the identification of Similar Devices. The presentation will focus on how such similar devices have to be chosen and how their performancescan be collected and documented.
Learning Objectives:
Delegates will learn a practical definition of State Of The Art, how to define it for their own devices and how to document it.
Delegates will have a clear perspective on where the IVD-R mandates the description of State Of The Art and in which processes SOTA is a keyelement.
Delegates will learn how to identify and document the "Similar Devices" required by the IVD-R in the definition of State Of The Art.
