Stay up-to-date regarding the EU MDR 2017/745 requirement which is impacting Medical Device manufacturers and which require that you appoint the Person Responsible for Regulatory Compliance.
This training is specifically for people that are interested to learn about the Medical Device Regulation EU MDR 2017/745.
The objective of this training:
It is a 1-week training that requires you to invest 2-3 hours per day to complete the course, assignments, quiz, and Live sessions. This is an intense program that will challenge you. It will provide you the big picture of the EU MDR 2017/745.
- Understand the context of the change between the Directive to the Regulation and also the understanding of the transition periods.
- Recognize the Economic Operators, to have a clear vision of their role and responsibility. And finally to understand the role of the Person Responsible for Regulatory Compliance.
- Identify all the steps to reach the market
- What is inside the technical documentation
- Explain the UDI and the interaction with EUDAMED
After the training week, you will be able to participate in an exam. This exam will cover all the 5 modules and should be executed within 60 minutes.
You will be successful if you reach 80%.