In this seminar on the topic of "IVD performance evaluation" you will learn how to demonstrate the performance of in vitro diagnostics in accordance with the IVDR. The seminar teaches you how to independently derive and justify an individual strategy for evaluating the performance of your IVD. With your seminar documents you will receive an IVDR-compliant document template for your performance evaluation plan.
During the seminar, you will use practical exercises to create your product-specific purpose, carry out the first steps of a systematic literature search, evaluate the applicability of analytical performance parameters and learn the most important things about the planning of clinical performance studies. With the skills you have acquired, you will be able to develop your product-specific plan on your own responsibility in order to safely pass the audit and establish high-performance products on the market.
We would like to point out that the time frame of the seminar is not sufficient to develop a product-specific performance evaluation strategy for each participant. Through the exercises and the joint exchange in the seminar, we provide you with the tools to do this independently. If you require specific support beyond this, you are welcome to ask us about it.
GoalsThe aim of the seminar is to give you the ability to plan the performance evaluation of your IVD individually and to implement the requirements of the IVDR product-specifically.
The objectives of the seminar are as follows:
- You know the regulatory requirements of the IVDR for the performance evaluation of IVDs.
- You understand the concept of clinical evidence .
- You know how important it is to have a precise purpose and you can formulate this specifically for your product.
- You know the required elements of the performance evaluation plan and develop your first product-specific draft.
- You know how to research the state of the art and how to prove the scientific validity by means of a systematic literature search.
- You know the required analytical and clinical performance parameters and know which guidance documents can help you with the practical implementation.
- You will learn how to justify the strategy for demonstrating clinical performance for your product and which influencing parameters you should take into account.
- You have an overview of which activities are to be implemented when during the performance evaluation process and how to document them in a "performance evaluation file" .
KONTAKT:
Online Seminar
