Learn UDI code for Medical Devices with Sylvia Reingardt
The UDI code is a new feature introduced by the EU MDR 2017/745 and IVDR 2017/746. It is here to increase traceability and transparency with its combination to the EUDAMED database.
In this Episode, Sylvia Reingardt from GS1 (One of the UDI code Issuing entity) will help us to understand the requirements. She will also share some of the mistakes that she experienced.
Within this episode, Sylvia will also share with us some details about GS1 as a Non-Profit Organization. This organization is also providing training and share with the public a lot of material within its website.
Check links below which contains the pages where all the UDI code information is available. Sylvia shared with us also the emails and phone numbers if you want to call GS1 Germany for more information.
Who is Sylvia Reingardt?
She is a sector manager for Healthcare at GS1 Germany. Prior to joining GS1 Germany in October 2011, she worked for 10 years for a service provider by managing international EDI projects and she was also involved in the development and introduction of new services. Sylvia also spent more than 10 years in the area of procurement at two university hospitals.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Sylvia Reingardt Linkedin Profile: https://www.linkedin.com/in/sylvia-reingardt-3272262b/
- GS1 Germany UDI landing page: https://www.gs1-germany.de/gs1-complete/branchenangebote/udi-umsetzung-mit-gs1-standards/
- Basic UDI-DI tutorial (german version): https://youtu.be/28N9NZ7UOPY
- GS1 Germany – Training (inhouse, online, at GS1 Germany): https://www.gs1-germany.de/no_cache/gs1-academy/weiterbildung/?tx_gs1seminars%5Bcategory%5D%5B80%5D=true#c1397
- GS1 Germany Consulting – Email to UDI-Beratung@gs1.de
- GS1 Global Office: https://www.gs1.org/industries/healthcare/udi
- Medtech Basic UDI-DI guideline: https://www.medtecheurope.org/resource-library/medtech-europes-guidance-on-basic-udi-di-assignment/
- Easy Medical Device Article on UDI: https://easymedicaldevice.com/udi
- Podcast Episode UDI: https://podcast.easymedicaldevice.com/4/
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