We are the MDR Eudamed specialists
Eudamed is very complex application with hundreds of different data requirements and business rules. Training is essential, it will save your organisation time and effort in needless research and analysis of the EC requirements.
We provide training both onsite in your premises and/or in varying managed locations for group workshops and training sessions. We provide various courses for the UDI Device requirements including the required eDelivery XML encapsulation. Courses cover the UDI Device and the machine to machine Data Exchange, covering the access point data encapsulations needed to send to the EC. In addition to the UDI Device XSD’s, XML formats, application business rules, and how to prepare your data for upload to the EC Eudamed database.
Later in 2019/ early 2020 we will provide courses covering the web input forms, the GUI. The GUI course will cover various MDR Eudamed modules that you will need and use. For example manufacturers will require UDI Device, Vigilance, and User management, where as notified bodies will be more concerned with the certificates module. Several parties will require training on Clinical Investigations and Vigilance.
Contact us to let us know your Eudamed training requirements and we can schedule the courses for you.