What is the Notified Body situation? (Bassil Akra from TUV SUD)
You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the Medical Device made Easy podcast, I have invited Dr. Bassil Akra, the VP of Strategic Business Development at TUV SUD. TUV SUD is one of the biggest Notified Body in the World.
Bassil will explain to us the current situation with Notified Bodies while we have a pandemic where Notified Bodies cannot perform on-site audits but also while we have a 1-year delay for the EU MDR application. So we hope that this episode will answer all your questions and that you will understand why getting an MDD 93/42/EC or AIMDD 90/385/EEC certification is something that is not easy anymore. You will understand also why during the next months you will not be able to issue a new certificate for a new Medical Device.
We will also talk about the “Devil” regulation which is renewing the accreditation of Notified Bodies without following the normal route. And you will understand why it is called the Devil regulation.
In the end, Bassil will also explain to you how it is to work at a Notified Body and all the benefits that you can get. Don’t forget to check the links below for more help.
Who is Dr. Bassil Akra?
Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service has a background in research, development, regulatory approval, and quality management of medical devices.
Dr. Akra is 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.
Dr. Akra presents worldwide on European requirements and is 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 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
For any Quality or Regulatory Affairs projects, please contact us through the EasyMedicalDevice.com website.
Links
- Dr. Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
- TÜV SÜD link: https://bit.ly/2ZyygJo
- Find a job at TÜV SÜD: https://www.tuvsud.com/de-de/karriere/stellen
- MDCG 2020-4: https://ec.europa.eu/docsroom/documents/40705
- Implementing Regulation 2020/666: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0666&from=EN
- Video: How to become a Notified Body Auditor?: https://www.youtube.com/watch?v=7z7tu-h6ppE
The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the Medical Device made Easy podcast, I have invited Dr. Bassil Akra, the VP of Strategic Business Development at TUV SUD. TUV SUD is one of the biggest Notified Body in the World.
Bassil will explain to us the current situation with Notified Bodies while we have a pandemic where Notified Bodies cannot perform on-site audits but also while we have a 1-year delay for the EU MDR application. So we hope that this episode will answer all your questions and that you will understand why getting an MDD 93/42/EC or AIMDD 90/385/EEC certification is something that is not easy anymore. You will understand also why during the next months you will not be able to issue a new certificate for a new Medical Device.
We will also talk about the “Devil” regulation which is renewing the accreditation of Notified Bodies without following the normal route. And you will understand why it is called the Devil regulation.
In the end, Bassil will also explain to you how it is to work at a Notified Body and all the benefits that you can get. Don’t forget to check the links below for more help.
Who is Dr. Bassil Akra?
Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service has a background in research, development, regulatory approval, and quality management of medical devices.
Dr. Akra is 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.
Dr. Akra presents worldwide on European requirements and is 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 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
For any Quality or Regulatory Affairs projects, please contact us through the EasyMedicalDevice.com website.
Links
- Dr. Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
- TÜV SÜD link: https://bit.ly/2ZyygJo
- Find a job at TÜV SÜD: https://www.tuvsud.com/de-de/karriere/stellen
- MDCG 2020-4: https://ec.europa.eu/docsroom/documents/40705
- Implementing Regulation 2020/666: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0666&from=EN
- Video: How to become a Notified Body Auditor?: https://www.youtube.com/watch?v=7z7tu-h6ppE
The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
