Why you should rely on a central data management system for UDI-MDR

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. There are numerous small and mid-sized companies (SMEs) with just a few or niche products […]

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20+ terms about MDR/UDI you should know

The medical device industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By implementing such complex regulations, there is a need for clarity on what´s meant by the various terms. In the numerous provisions of the UDI regulations alone, many terms need to be known. We […]

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All About the UDI Regarding MDR

The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2020 (edit: postponed to 2021) and represents a further large-scale revolution in the industry. In addition to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. UDI labeling […]

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