Technical Documentation of Medical Devices & Impact on the EUDAMED database

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

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