About this e-learning
This e-learning is about Vigilance Reporting for EU MDR and IVDR. The training will focus around Article 87 (EU MDR) and article 82 (EU IVDR). It will provide all the expert advice to execute a vigilance reporting for your company.
Key learning objectives
By the end of this course, you will be able to:
- Recognize what is an incident (event) and how to handle it within your company.
- Identify the structure of your Quality Management System for handling vigilance reporting.
- The EU MDR and IVDR parameters to take into account.
- The documents that you need to provide to the authorities for executing the vigilance reporting.
- The definition of Trend Reporting. And how to establish a process to identify it within your company.
Who should attend?
This Vigilance Reporting training is helpful for all medical device professionals and management and executive personnel looking to expand their knowledge on the EU MDR and IVDR
By completing this course, you will receive a certificate of participation.