All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes which are Class I sterile (Is), Class I with a measuring function (Im) and the new Class I for surgical reusable devices (Ir). When class I products are Self-Certified, you should know that this is not the case for class I special devices.
Elem Ayne from ACR Medical will help us understand the difference and what should be done to have compliant medical devices. She will also tell you what will be checked during an audit. This part is really important. Don’t forget also to download the presentation that Elem prepared for you.
Who is Elem Ayne?
Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France). She has started her career in R&D in microbiology, oncology, and biochemistry.
She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality and regulatory affairs for different industries, in particular in sterilization.
She has finally specialized herself in Regulatory affairs working especially in Class I reusable granted by a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745.
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…
Links from the Video
- Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/
- Presentation to download: https://mailchi.mp/easymedicaldevice/class_i_special