Just three years ago, a deadline extension for the MDR implementation was under discussion, which was desired above all by the manufacturers. The deadlines remained unchanged, which was quickly determined. However, the question of how to stem the upheaval in the medical technology industry remained unanswered. The biggest concern is probably the lack of notified […]
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 industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By enforcing such complex regulations, there is a need for clarity on what´s meant by the various terms. Alone in the numerous provisions of the UDI regulations, many expressions need to be known. We […]
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 […]