Arkan Zwick Q&A, Part 1: Choosing An EU Notified Body For Drug/Device Combinations In A Rapidly Changing Environment
Selecting a notified body that has capacity, expertise and staying power is a challenge in itself. But when it comes to selecting a good one for drug/device combinations products, how should companies proceed? Croma Pharma executive Arkan Zwick offers his insight in this first part of a two-part Q&A. Check out the second part here.
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Croma Pharma executive Arkan Zwick talks about the challenges of getting the drug element of a device-type drug/device combination product reviewed in the EU and how companies should proceed in selecting a notified body to review combinations.
In the second half of a Q&A with Medtech Insight, Croma Pharma executive Arkan Zwick talks about the challenges of getting the drug element of a device-type combination product reviewed in the EU and what combo-product firms have to look out for under the oncoming Medical Devices Regulation. Read the first part of the conversation here.
Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.