Latest / Medical Device made Easy Podcast
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…
The skinny
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