Learn UDI code with Sylvia Reingardt (EU MDR 2017/745 & IVDR 2017/746)
► Webpage: https://podcast.easymedicaldevice.com/86/
The UDI 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 Issuing entity) will help us to understand the requirements for UDI. 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
-----------------------------------------------------------------------------------------------------------------------------
► 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.
■ GS1 Germany
Contact details: Sylvia Reingardt, Senior Manager Healthcare, sylvia.reingardt@gs1.de
UDI Support at GS1 Germany: Tel: +49 221 94714-834 (Mo.-Fr. 9-17 Uhr)
E-Mail: UDI-Support @ gs1.de
-----------------------------------------------------------------------------------------------------------------------------
► 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 - UDI 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 UDI 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/
-------------------------------------------------------------------------------------------
► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
------------------------------------------------------------------------------------------
#easymedicaldevice #medicaldevice #compliance
Видео Learn UDI code with Sylvia Reingardt (EU MDR 2017/745 & IVDR 2017/746) канала Easy Medical Device
The UDI 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 Issuing entity) will help us to understand the requirements for UDI. 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
-----------------------------------------------------------------------------------------------------------------------------
► 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.
■ GS1 Germany
Contact details: Sylvia Reingardt, Senior Manager Healthcare, sylvia.reingardt@gs1.de
UDI Support at GS1 Germany: Tel: +49 221 94714-834 (Mo.-Fr. 9-17 Uhr)
E-Mail: UDI-Support @ gs1.de
-----------------------------------------------------------------------------------------------------------------------------
► 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 - UDI 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 UDI 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/
-------------------------------------------------------------------------------------------
► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
------------------------------------------------------------------------------------------
#easymedicaldevice #medicaldevice #compliance
Видео Learn UDI code with Sylvia Reingardt (EU MDR 2017/745 & IVDR 2017/746) канала Easy Medical Device
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
![How to comply to the GSPR ? (EU MDR and IVDR - Monir El Azzouzi)](https://i.ytimg.com/vi/iaE_gbhfW5U/default.jpg)
![Understand IEC 62304 for Software Medical Devices with Adnan Ashfaq](https://i.ytimg.com/vi/8UtCRFYe5XU/default.jpg)
![How a QA RA Training can help your Company? [Sofmedica]](https://i.ytimg.com/vi/jVzDa0MBsdA/default.jpg)
![How to regulate Self Testing with the new IVDR 2017/746?](https://i.ytimg.com/vi/qcEXpbetCDE/default.jpg)
![Q&A Session - No more secrets on Economic Operators [MDG Premium call]](https://i.ytimg.com/vi/Q61DL1mYGZY/default.jpg)
![All secrets on UDI: Unique Device Identification (MDR 2017/745 & IVDR 2017/746)](https://i.ytimg.com/vi/zzb_GTEDmxY/default.jpg)
![Ready for a successful MDR or IVDR Audit (Martin Witte - TÜV SÜD)](https://i.ytimg.com/vi/Oa7jwL-HxgI/default.jpg)
![What means Sufficient Clinical Data with Bassil Akra (EU MDR)](https://i.ytimg.com/vi/plNtXt9UeX8/default.jpg)
![What are the changes to ISO 14971 2019? (REPLAY) #medicaldevice](https://i.ytimg.com/vi/5C2CzApjI_U/default.jpg)
![How much does Cost the new Medical Device Regulation [2017/745]](https://i.ytimg.com/vi/A6rkJAO8Vkw/default.jpg)
![How to choose your PRRC ? (EU MDR 2017/745 - IVDR 2017/746)](https://i.ytimg.com/vi/e8xT1hAR0ao/default.jpg)
![Sufficient Clinical Data - The systematic approach [Cesare Magri]](https://i.ytimg.com/vi/TAjsSWZn0xc/default.jpg)
![How to perform Product Equivalence on your CER (Clinical Evaluation Report)?](https://i.ytimg.com/vi/xIeL297EOho/default.jpg)
![What can we learn from 100 days of audits (EU MDR 2017/745)](https://i.ytimg.com/vi/-5bG_E7ndrs/default.jpg)
![UDI and the EU MDR What You Need to Know to Comply](https://i.ytimg.com/vi/VodgtZn3W5Y/default.jpg)
![What are Common Specifications within MDR & IVDR? [Stefan Bolleininger]](https://i.ytimg.com/vi/_5bdNbG1MyY/default.jpg)
![How to get some help from Medical Device regulators?](https://i.ytimg.com/vi/ZYEsRLN83gQ/default.jpg)
![How to classify a Medical Device? (EU MDR Case Studies)](https://i.ytimg.com/vi/JXuLft-IEZg/default.jpg)
![Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)](https://i.ytimg.com/vi/TUV6fLio_FU/default.jpg)
![How GDPR impacts the Medical Device Industry with Erik Vollebregt](https://i.ytimg.com/vi/lrox-Jq_fI4/default.jpg)