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?
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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.
