Why do we need the Common Specification for Class D IVDR?
For IVDR products, there is more and more information that is coming.
So we make a small summary with Andreas Stange from TÜV SÜD and then we will discuss specifically the Draft Common Specification for certain Class D devices.
Andreas will explain to you why we need these common specifications and if this is mandatory. He will also explain the problem that comes now when the transition date for certain devices were extended.
Andreas will also invite you to join TÜV SÜD if you are interested to be part of this Notified Body as an auditor. Multiple places in the world are looking for you.
I hope this will be informative to you.
Who is Andreas Stange?
Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.
Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs.
After working for many years with big Healthcare companies 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
- Andreas Stange Linkedin: https://www.linkedin.com/in/andreasstange
- Common Specification IVDR: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
- TÜV IVDR application: https://bit.ly/3HKGxw0
- IVDR episode: https://podcast.easymedicaldevice.com/26