How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why?
Because there are less than what we need and because it is difficult to budget their service. So I have invited the Head of the TÜV SÜD Healthcare Business Unit to tell us more about the Notified Body Situation.
We will discuss:
- The increase of Notified Body Scope
- The Covid Restrictions
- The strategy US – EU for market access
- The cost of Notified Bodies
- When to contact a Notified Body?
- Annex XVI products
- The IVDR proposal to delay some of the product classes
So if you need to understand better the situation of Notified Bodies and how to work with them then this is the Podcast to listen to.
Who is Dr Royth von Hahn?
Dr. Royth von Hahn has taken over as the new Business Unit Manager Medical & Health Services (MHS) at TÜV SÜD Product Service. Operating from San Diego (USA), he will be responsible for a network of around 600 experts and a portfolio of lifecycle services for medical devices, from product design to risk management and approval. Dr von Hahn succeeds Dr. Peter Havel, who transfers to TÜV SÜD Product Service GmbH in Munich as CEO.
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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
- Dr Royth von Hahn profile: https://www.tuvsud.com/en/press-and-media/2018/january/dr-royth-von-hahn-responsible-for-medical-health-services-at-tuv-sud
- TÜV SÜD healthcare: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-conformity-assessment-procedures