015 - "Would You Use it on a Family Member?" with Monir El Azzouzi

On this episode of the podcast we had Monir El Azzouzi of Easy Medical Device. Monir and I focus on EU MDR and discuss the difference between EU MDR and US regulations, the history of the MDD being updated to MDR in 2017, Notified Bodies(their role and how they are formed), CE Marking and medical device clearance, considerations for CMO’s and private label, the role of Authorized Representatives, books be recommends and the importance of thought and integrity in QA.  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. If you'd like to support the show, please share, subscribe and rate on Apple Podcasts and Spotify. If you have any feedback or requests please contact combinatepodcast@gmail.com.