EDA
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
FDA
The article describes in detail the approach to be applied with respect to clinical performance testing considerations including, inter alia, the ones associated with treatment parameters and protocols, safety and effectiveness endpoints and data, as well as adverse events
EU MDR/IVDR
The article provides an overview of the new regulation and highlights the key points associated thereto.
FDA
The article provides an overview of the new regulation and highlights the key points associated thereto.
Medical Devices
This article highlights he differences between intended use and indications of use, along with their significance. Table of Contents In the highly regulated world of medical devices, precision in terminology makes a significant impact. It is important for preparing...
