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Why Expert Panel will review Clinical Evaluation Reports? [EU MDR]
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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.
We can guide you on this process.
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►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.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
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► Social Media to follow
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#easymedicaldevice #medicaldevices #regulatoryaffairs
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.
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.
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
-------------------------------------------------------------------------------------------
► Social Media to follow
------------------------------------------------------------------------------------------
#easymedicaldevice #medicaldevices #regulatoryaffairs
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