How to interpret the first Expert Panel Opinion? [Bassil Akra]
We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode.
We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid certain issues when you have to go through this process.
If you want to get this document, you have the link below.
Who is Dr. Bassil Akra?
Dr. Bassil Akra, CEO of Akra Team has a background in research, development, regulatory approval, and quality management of medical devices. Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.
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 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, Podcast, Online courses…
Links from the Video
- Akra team website: https://www.akrateam.com
- Bassil Akra Linkedin Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
- Episode 102 – What are expert panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/
- First Expert Panel Opinion: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/2021-000201_nb0483_opinion.pdf
- Clinical Pack: https://school.easymedicaldevice.com/product/clinical_pack/