An important component of Medical Device Regulation (MDR), the launch of EUDAMED, has been postponed by two years to May 2022. However, May 2020 remains the date for the other elements of the MDR. It was considered unlikely that the deadline for the MDR would be postponed. However, the European Union now announced that at […]
A single point of truth (SPOT) for data or document management is a must in highly regulated markets combined with increasing digitalization. Even small and mid-sized companies can hardly avoid this if they want to keep up with the market. Therefore, it is important to consider the advantages of a centralized data management system. There […]
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The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2021 and represents a further large-scale industry revolution. In addition, to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. The USA introduced UDI labeling as early as […]