UDI EUDAMED Training
The implementation of the European Commission’s Medical Device Regulation (MDR 2017/745 & IVDR 2017/746) is a major challenge for all medical device manufacturers, importers and distributors. Due to the high complexity of the information as well as frequent temporal and technical changes of the EUDAMED, it is essential to acquire expert knowledge in order to avoid future mistakes that could have a severe impact on your medical devices and sales.
To make this complex process as efficient and effective as possible, we offer a comprehensive UDI EUDAMED online training. In this one-time, full-day training, we explain the entire process of EUDAMED implementation, from the authority’s data requirements to data submission to EUDAMED.
The UDI EUDAMED training is adapted to all EUDAMED stakeholders and is aimed at specialists and managers from the areas of regulatory affairs, quality management and IT from medical technology and all other EUDAMED interested parties.
Ensure optimal UDI data management and accurate and timely UDI compliance with the UDI EUDAMED training.
Agenda:
- Status Update EUDAMED
- UDI Deadlines
- EUDAMED structure & applications
- UDI Data Requirements
- Global Model Number (GMN) Requirements & Generation
- UDI Business Rules (MDR/IVDR)
- Legacy Medical Devices (MDD/ IVDD/ AIMDD)
- EUDAMED Registration (Actors & SRN)
- EUDAMED Playground
- Data submission options
- Q&A
Appointment Request:
If you would like to participate in an UDI EUDAMED training or would like to register a training for a closed group, please send us an appointment request.