Let’s unleash “MDR Classification surprises” [MDR 2017/745]

Medical Device made Easy Podcast

Monir El Azzouzi에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Monir El Azzouzi 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

2+ y ago

MP3•에피소드 홈

Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related to the new EU MDR 2017/745. We will also discuss a bit of the EU MDD 93/42/EC

Who is Frank Matzek?

Frank Matzek is a Medical Device expert with 40 years of experience. He worked within a Test and Certification body called BerlinCert where he was the technical expert. Then he entered BIOTRONIK as Regulatory Affairs Manager and didn’t leave it until now. He is now the Vice-President of Regulatory & Government affairs. Additionally, Frank is also part of the BVMed as a member and vice-chair of the Regulatory Affairs Committee (AKRA) and lastly member of the MedTech Europe.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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, podcasts, Online courses…

Links from the Video

Frank Matzek Profile: https://www.linkedin.com/in/frank-matzek-a43617/
Biotronik website: https://www.biotronik.com/?campaign=linkedinus
MDCG 2021-24: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
MEDDEV classification guidance: https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

Medical Device Classification MDR 2017/745 - Frank Matzek Biotronik & Monir El Azzouzi Easy Medical Device

The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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