Elements of the Data Model:
from Documents to Knowledge
We identify single information units (“Knowledge Units”) contained in single documents of the technical documentation. Our goal is the provision of a data model that consists of all Knowledge Units required for compliance with requirements of MDR, Annex II and III.
Extraction of single information units in documents:
List of required information units for compliance with MDR, Annex II and III:
Terms, Definitions and Application
We use two terms in the context of our data model: Knowledge Topic (KT) and Knowledge Unit (KU). The KT represents the template: a description what is required from a regulatory point of view. The KU is created on the basis of the KT for a particular medical device and contains specific information related to the device.
Terms and Definitions
Hierarchy in the Data Model
In addition to definitions for single data model elements, we provide information about the hierarchy of individual knowledge topics, from a general, higher level down to very specific elements of the data model at lower levels.
Example for KT Hierarchy
Content of a Knowledge Topic
For each Knowledge Topic, we provide a clear description, attributes and additional information on the application of the Knowledge Topic, as well as background information explaining the regulatory basis of the chosen description.