Why Should You Attend:
The new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately action is required. Without the new certificates your sales activities in Europe are interrupted.Areas Covered in the Webinar:
The new scope of the EU IVDR 2017/746
The obligations and roles of the EU IVDR 2017/746
How work the regulation and the EN ISO 13485:2016 together?
New and updated processes required by the EU IVDR 2017/746
How to implement the required changes until May 2022?
The new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately action is required. Without the new certificates your sales activities in Europe are interrupted.Areas Covered in the Webinar:
The new scope of the EU IVDR 2017/746
The obligations and roles of the EU IVDR 2017/746
How work the regulation and the EN ISO 13485:2016 together?
New and updated processes required by the EU IVDR 2017/746
How to implement the required changes until May 2022?
