In a scoping workshop (which can also be booked as a separate entry-level workshop), we work with you to analyse the UDI requirements for your company, and consider potential approaches for implementation and validation. Typical workshop topics include the system environment, the structure of products and product groups, labelling and interfaces to existing applications, etc. We determine the work packages that need to be completed and consider potential responsibilities for implementation.
Starting with our solution as the basis, definitions are then needed for the mapping of the individual UDI attributes, the steps in the maintenance process and the transfer of data to the FDA or EUDAMED. Depending on data volume and the frequency of changes, the degree of automation also needs to be specified. In the same way, the respective authorisations also need to be defined. Additional requirements (attributes) for other regions may need to be accounted for here as well – although our model is so flexible that future requirements can also be added as needed at any time.