EU MDR Training - FAST-TRACK
Easy Medical Device is honored to organize the first Fast-Track training on EU MDR 2017/745. We will mix training information and workshops. We really hope you will enjoy what we prepared for you.
Training Agenda
During 2,5 days you will be provided all the information needed on EU MDR 2017/745. Below are the topics that will be covered during this training. (The agenda may change slightly).
- EU MDR overview: Timeline situation, significant changes
- Qualification, Classification, Conformity Assessment, Notified Bodies
- Workshop: Significant Changes and Classification case studies
Group event surprise
- Quality Management System under MDR
- Technical Documentation
- eQMS: Manage your documentation.
- Workshop: Structure your Technical File under MDR
- Clinical Evaluation
- PMS/PMCF
- Workshop: CEP, CER, Literature search structure
Group event surprise
- Economic Operators
- PRRC role and responsibility
- Workshop: PRRC Case Study
- EUDAMED & UDI
At the end of the training, a certificate of participation will be provided. All the presentations and material will be accessible and sent to you electronically.
Additional information
Pre-requisite: The main pre-requisite for the full benefit of this training is to have a minimum knowledge of the Medical Device legislation for CE marking (MDD or AIMDD). But this is convenient for beginners.
Offer Package: The training price includes also Hotel, lunch, and coffee breaks during the event, and also the events that we are planning on Monday and Tuesday evenings.
1 to 1 sessions: During this training, short private sessions to discuss the specifics of your situation can be organized with the experts. This may include an extra charge that is not included in this price. To be discussed with the experts.
All inclusive
Description
- Hotel Room included
- Lunch/Coffee break Included
- Special evening events Included
Course only
Description
- Lunch/Coffee break Included
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