What means Sufficient Clinical Data with Bassil Akra (EU MDR)
You are maybe trying to build your Clinical Evaluation Report or your PMCF for a Medical Device. And you are stuck because you don’t really understand what means Sufficient Clinical Data?
Then listen to this interview with Bassil Akra from QUNIQUE Group, who is sharing with us his experience as a former TÜV SÜD auditor.
He also participated in the different groups to prepare the guidance that we will discuss today.
During this interview we will discuss:
- The difference between MDD 93/42/EC or AIMDD 90/385/EEC and MDR 2017/745 in terms of clinical data
- The meaning of Sufficient Clinical Data
- The Essential Requirements or General Safety and Performance Requirements for Clinical Data
- The Product Equivalence chapter
- The PMCF rules
- The Expert panel
Bassil Akra will also present to us a Webinar that he will lead to help Medical Device manufacturers deal with the amount of data they should collect to pass an EU MDR audit.
The first session will be on June 8th for the EU time zone and June 11th for the US time zone. Another session will be planned for other timezones.
Who is 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…
Don’t hesitate to contact firstname.lastname@example.org for more information.
- Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
- QUNIQUE Group: https://quniquegroup.com/
- QUNIQUE Training: https://quniquegroup.com/TRAININGS/
- MEDDEV 2.7/1 rev 4: https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
- MDCG guidance 2020-6: https://ec.europa.eu/docsroom/documents/40904
- FREE PMCF Plan Template: https://school.easymedicaldevice.com/product/pmcf-plan-template/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Telegram Channel: https://t.me/easymedicaldevice
- Youtube Channel: https://youtube.com/c/EasyMedicalDevice?sub_confirmation=1
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice