Obelis offers a range of dedicated training sessions conducted by industry experts designed to make your organization familiar with the EU legislation surrounding medical devices.
The content of our training courses can be customized according to your needs. This makes our trainings suitable for those new to the EU market as well as regulatory and/or quality staff seeking to increase their regulatory expertise.
Our training courses can be attended online or performed on-site.
MDR – IVDR TRAINING PROGRAM
In light of the new EU regulations, we proudly present Obelis MDR & IVDR Training Program. The training courses are designed to prepare manufacturers for compliance with the EU MDR & IVDR and cover among others the below topics:
- MDR & IVDR Transition Highlights & Strategies;
- New Essential Requirements & Conformity Assessment Routes;
- Technical File Requirements – Gap Analysis from Directive to Regulation;
- EUDAMED, UDI, PRRC;
- New Requirements for Economic Operators;
- MDR/IVDR ON-SITE TRAINING: This training aims to provide in-depth technical and practical knowledge about the MDR & IVDR. During a 1 or 2-day training course, industry experts focus on the operational impact of the new regulation(s) and offer tools to determine the best compliance strategy for your business
- MDR/IVDR ONLINE TRAINING: This training summarizes the most relevant topics of the MDR & IVDR. During 2 hours, we highlight the important changes of the new legislation with a Q&A session.
Please click here for a quotation or click below on the on-site training service request form to get a tailored offer.