Visualize and compare complex data models at once – with the Data Elements Explorer

Due to the increasing UDI requirements in different markets, product registration for medical devices is becoming significantly more complex. Part of our daily work at p36 is to review and compare the different country requirements and to derive the best possible strategy to cover those requirements with acceptable effort.

In this context, the registration of product master data required by the authorities play a central role.  We ask ourselves every day – as we are sure you do – how transparency and structure can be introduced into this mass of data requirements.

Our answer? The Data Elements Explorer (DEE). The DEE allows you to visually analyze the so-called data models of the authorities and even compare models of different authorities (e. g. FDA and NMPA) with each other. This gives you a comprehensive overview of the differences, but above all the similarities of the requirements in different markets. In turn, this helps you to build up your internal UDI data management. In our UDI Platform we achieve this via the Common Device Model (CDM). The CDM is responsible for maintaining data required by several authorities once in the system, releasing it and transferring it to the respective controlled vocabulary of an authority by means of an intelligent translation.

What are the benefits of the Data Elements Explorer?

Especially for the responsible persons in the field of Regulatory Affairs and UDI as such, the DEE offers the possibility to both, gain insight into the UDI data of the respective authorities and to compare them with other authorities.

Bringing transparency to the requirements and, based on this, developing a suitable strategy for data collection and transmission to the authorities are in our view the core tasks in the increasingly complex UDI world. The Data Elements Explorer and the creation of the most comprehensive base of reusable product master data (CDM) precisely enables this.

The core functions of the Data Elements Explorer at a glance:

  • Graphical analysis of individual data models of the authorities

  • Graphical comparison of the data models of different authorities

  • Graphical comparison of the internal UDI data pool (Common Device Model) with data models of the authorities

  • Analysis of data elements and their characteristics (Controlled Vocabulary)

Data elements explorer data models
Insight into DEE with list of data models on the left, data elements within data models in the middle and details of selected data elements regarding data on the right.
Data elements explorer data comparison
Comparison of the data models FDA and NMPA.

The Data Elements Explorer is available since our latest release 2.5 of the UDI Platform.

Are you interested in a demo of our UDI Platform including the Data Elements Explorer and Common Device Model? Please do not hesitate and contact us.

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