How to get the MDR certification for Artificial Intelligence Softwares?
Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745.
For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what is really artificial intelligence, then we will talk about the classification of SaMD or Software as Medical Devices.
Leon will also tell us what went well and what was really a struggle for him. We will also talk about the Notified Body support. So if you are a company that develops SaMD or AI software then this episode is for you.
Don’t hesitate to contact Easy Medical Device (email@example.com) if you have some SaMD project. We can help you with it.
Who is Leon Doorn?
Leon is responsible for Regulatory Affairs within Aidence, a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.
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 a 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 and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Leon Linkedin Profile: https://www.linkedin.com/in/leondoorn
- Email: Leon@aidence.com
- Podcast episode Cybersecurity: https://podcast.easymedicaldevice.com/67/
- Will the MDR improve regulatory oversight of AI solutions?: https://www.aidence.com/articles/mdr-oversight-of-ai-solutions/
- Regulations are rapidly evolving, but do they match technology?: https://www.aidence.com/articles/regulations-ai-medical-device/