We are the MDR Eudamed specialists
Eudamed is very complex application with hundreds of different data requirements and business rules. The EC have published many of the documents required for companies to proceed IT projects, the publication links are available here. Everything companies need to proceed has been published. Because of the complexity we feel training is essential, it will save organisations time and effort in needless research and analysis of the EC requirements.
We provide training both on- and off- site in various managed locations for group training sessions. We provide courses for IT personnel to understand the complexities and dependencies of the EC publications. Courses cover the UDI Device, and the machine to machine Data Exchange, even covering the access point data XML encapsulations needed to send submissions 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.
Courses covering the main web application and web input forms, will be available closer to the launch date of MDR Eudamed. This 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.
Our scheduled training dates are available here.