Objective: The objective of the training is to provide guidance on the process to comply with the Technical Documentation of Medical Devices, under the EU Regulation 2017/745 and how it impacts the new EUDAMED database.
At the end of this workshop, you will be able to:
- Define how much the Technical Documentation of your organization complies with the MDR.
- Understand the information gathering system within the context of your quality and risk management systems.
- Analyze in detail compliance with regulatory requirements and post-market surveillance.
- Identify and create the necessary links between your process, the QMS and risk management processes.
- Create a Technical Document based on the MDR.
- Understand the function of the EUDAMED database.
- Determine if your company is in compliance with EUDAMED
- Prepare the actions to be in the EUDAMED database