We are the MDR Eudamed specialists
EUDAMED is a very complex application with an abundance of different data requirements and hundreds of business rules. Because of the complexity of the published information by the European Commission and the possibility of companies making costly mistakes we feel EUDAMED training is essential, it will save organisations time and effort in needless research and analysis of the EC requirements, in addition to mitigating the risk of costly mistakes.
We provide training both on- and off-site in various managed locations for group training sessions in addition to providing online training.
We have two EUDAMED courses available, technical and non-technical.
1. The technical course is aimed at 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.
2. The non-technical course is for RA/QA’s, management, consultants, and interested parties, it covers the basics of the IT side, just for gaining an understanding but not overly technical as these participants will not be implementing IT systems. In addition to the basics of the inner workings of EUDAMED, the course also covers the main web application and UDI Device, Actors and User management web input forms. This course covers the MDR EUDAMED modules that you will need and use most.
In addition to scheduled courses that we deliver we are also licencing our training program directly to manufacturers so their inhouse trainers can deliver the courses. We are also licensing the course to selected training companies who can deliver our courses to their clients worldwide, please complete the form below to receive more information.
Our scheduled training dates, prices, and agenda are available here.
Apply for more information on licencing our EUDAMED training courses.