Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
The EU MDR 2017/745 is increasing the requirements for Clinical Evaluations. In this episode, I will be with Dr. Bassil Akra from QUNIQUE and we will explain to you the different levels of reviews that exist and specifically about the Expert Panel.
You would maybe ask “What is this?”.
Don’t worry, we will explain to you and even provide you with more information also on some voluntary consultation that this group can provide.
In case you need some support for your Clinical Evaluation Reports, UK responsible process, Technical File review, Training for EU MDR, don’t hesitate to contact us at info@easymedicaldevice.com We can guide you on this process.
Who is Dr. Bassil Akra?
Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group 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.
In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.
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 company 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, Podcast, Online courses…
Links
- Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
- QUNIQUE Group: https://quniquegroup.com/
- EXPERT PANEL EU: https://ec.europa.eu/health/md_expertpanels/overview_en
- MDCG 2020-13: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-13-cea-report-template_en.pdf
- Episode 78 – Sufficient Clinical Data: https://podcast.easymedicaldevice.com/78
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