Clinical evidence for IVD. Why you should use CLSI.

Discover the gold standard for in vitro diagnostics: How CLSI assessment protocols lead the way.

At the heart of modern medicine is an invisible foundation that underpins the reliability and certainty of every diagnosis: clinical evidence. Especially in the field of in-vitro diagnostics (IVDs), this evidence is the key that not only guarantees the accuracy of test results, but also strengthens trust between patients and healthcare professionals. But what exactly do we mean by clinical evidence in the context of IVDs and why is it so crucial for diagnostics?

In this article, we explore the central role of clinical evidence in modern diagnostics and highlight how the CLSI guidelines help to create this evidence-based data. These guidelines provide detailed instructions for the collection of data on the analytical performance of in vitro diagnostics and are essential for the development of reliable diagnostic methods. They form the basis for moving from raw data to trustworthy and validated results.

Would you like to learn more about the central role of clinical evidence in modern diagnostics and understand why CLSI guidelines are the key to reliable and validated test results? Then sign up now and receive our latest blog article "Clinical Evidence for IVD - Why you should use CLSI" by Dr. Sebastian Grömminger directly in your inbox.

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About the author.
Dr. Sebastian Grömminger. Principal Consultant IVD.

Dr. Sebastian Grömminger holds a degree in molecular biology from Goethe University in Frankfurt am Main and completed his doctorate at Helmholtz Zentrum München.
Dr. Grömminger is an expert in in-vitro diagnostic medical devices, quality management, regulatory affairs and risk management. He has extensive knowledge of software life cycle compliance according to EN (IEC) 62304 and usability according to EN (IEC) 62366, as well as experience in assay development and performance evaluation. As a consultant for the approval of in-vitro diagnostics, he has carried out or managed over 30 successful projects. As a lecturer for regulatory affairs, he has extensive expertise in the areas of technical documentation for IVD, IVD detection and measurement methods, as well as the development of online training courses for the practical implementation of the IVDR.

Dr. Sebastian grömminger

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