EU MDR/IVDR
The article provides an overview of the FAQ document addressing the key points related to notifications for medical devices. Table of Contents SwissMedic, a country’s regulating authority in the sphere of healthcare products, has published a guidance...
FDA
The new article describes in detail the approach to be applied with respect to an investigation plan and also provides definitions of the most important terms and concepts used in the context of the guidance. Table of Contents The Food and Drug Administration (FDA or...
Saudi Arabia
The document provides an overview of the regulatory approach to be applied with respect to medical devices based on innovative technologies for data processing. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the...
FDA
The new article addresses the aspects related to the way study results should be analyzed, and also the ones related to changes made by a study sponsor to a pre-defined study design after the study itself has commenced. Table of Contents The Food and Drug...
FDA
The new article highlights the aspects related to behaviors considered denying or limiting an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft...
FDA
The new article highlights the key points to be considered when conducting a study in order to sustain its quality, as well as to ensure the accuracy and reliability of its result. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
